<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01711294</url>
  </required_header>
  <id_info>
    <org_study_id>90869947</org_study_id>
    <secondary_id>E7084</secondary_id>
    <nct_id>NCT01711294</nct_id>
  </id_info>
  <brief_title>Evaluation of PCLs Using Three EUS-FNA Needles</brief_title>
  <official_title>A Multicenter, Prospective, Randomized Study on Endosonographic Evaluation of Pancreatic Cystic Lesions Using 22 G, 19 G, and Flexible 19 G Fine Needle Aspiration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Scientific Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To document impact of EUS-FNA needle size and flexibility on effectiveness of pancreatic&#xD;
      cystic lesions (PCL) aspiration, on ability to obtain sufficient material for standard&#xD;
      diagnostic testing, and on diagnostic accuracy of EUS-FNA aspirate for differentiation of&#xD;
      mucinous (pre-malignant) and non-mucinous cysts.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 8, 2013</start_date>
  <completion_date type="Actual">December 18, 2019</completion_date>
  <primary_completion_date type="Actual">June 6, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Volume of Aspirated Cyst Fluid as a Function of Estimated Maximal Volume</measure>
    <time_frame>At procedure (Up to 1 hour)</time_frame>
    <description>Volume of aspirated cyst fluid as a function of estimated maximal volume, based on pre-aspiration EUS measure of cyst diameter (s) (% aspiration of total estimated volume)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Related Adverse Events</measure>
    <time_frame>30 days</time_frame>
    <description>Adverse events related to study procedure or study device were tabulated. Adverse events were assessed from the index procedure up to 30 days post procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Volume of Cyst Post Initial Procedure Compared to Pre Procedure</measure>
    <time_frame>Procedure (Up to 1 hour)</time_frame>
    <description>Change value is calculated as cyst volume measured after initial procedure (up to 1 hour) minus volume measured at the beginning of the initial procedure. Volume is measured using the standard geometric formula 4/3 πr³ where r is half the long axis. The volume unit is cc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Successful Echoendoscopic Fine Needle Aspiration of PCL</measure>
    <time_frame>Procedure (up to 1 hour)</time_frame>
    <description>Successful echoendoscopic fine needle aspiration of PCL, defined as complete cyst aspiration (final cyst maximal diameter of less than 5mm) or collection of aspirate adequate to perform two standard assays: cytology and carcinoembryonic antigen (CEA) (sample volume of 3 cc or more)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With PCL Reached/Penetrated</measure>
    <time_frame>Procedure (Up to 1 hour)</time_frame>
    <description>Patients whose pancreatic cyst lesion(s) can be reached and penetrated by the EUS-FNA needles.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of EUS-FNA Needle Passes at Initial Procedure.</measure>
    <time_frame>Procedure (Up to 1 hour)</time_frame>
    <description>Needle pass defined as needle insertion through needle removal outside the cyst lumen, but not including needle repositioning within a single or multi-compartment cyst.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of EUS-FNA Needles Used at Initial Procedure.</measure>
    <time_frame>Procedure (Up to 1 hour)</time_frame>
    <description>Total number of EUS-FNA needles used across all participants at the initial procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time Needed for Aspiration for Each Needle Pass at Initial Procedure.</measure>
    <time_frame>Procedure (Up to 1 hour)</time_frame>
    <description>Needle pass is defined as needle insertion through needle removal outside the cyst lumen, but not including needle repositioning within a single or multi-compartment cyst.&#xD;
Time of needle pass in is time of the first needle puncture into the cyst lumen. Needle pass out is time of removal of needle outside the cyst lumen, or after 10 seconds of failed attempt to aspirate fluid after the last needle re-repositioning in a single or multi-compartment cyst.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time From First Needle Pass in to Last Needle Pass Out at Initial Procedure.</measure>
    <time_frame>Procedure (Up to 1 hour)</time_frame>
    <description>Needle pass is defined as needle insertion through needle removal outside the cyst lumen, but not including needle repositioning within a single or multi-compartment cyst. Time of first needle pass in is time of the first needle puncture into the cyst lumen. Time of last needle pass out is time of removal of needle outside the cyst lumen at the end of the last fluid aspiration from a single or multi-loculated cyst, or after 10 seconds of failed attempt to aspirate fluid after the last needle re-repositioning in a single or multi-compartment cyst.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Needles With Needle Insertion Rated as Excellent/Very Good</measure>
    <time_frame>Procedure (Up to 1 hour)</time_frame>
    <description>Number of needles rated either Excellent or Very good when inserted into the echoendoscope at the initial procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Needles With Needle Removal Rated as Excellent/Very Good</measure>
    <time_frame>Procedure (Up to 1 hour)</time_frame>
    <description>Number of needles rated either Excellent or Very good when removed from the echoendoscope at the initial procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Needles With Needle Visualization Rated as Excellent/Very Good</measure>
    <time_frame>Procedure (Up to 1 hour)</time_frame>
    <description>Number of needles rated either Excellent or Very good for visualization at the initial procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Accurate Diagnosis of the Disease State Using the EUS-FNA Needles</measure>
    <time_frame>up to 2 years</time_frame>
    <description>In order to assess the accuracy of EUS-FNA-based standard assays (cytology and CEA) as a diagnostic measure of disease state, the Disease State per EUS-FNA measure was compared to a reference diagnosis. The reference diagnostic standard was diagnosis from a surgical specimen histology, the true gold standard for cases that evolved to surgical resection within the follow-up of the study. For cases that did not progress to surgery within the follow-up period, the reference diagnostic standard was a composite diagnosis by a consensus board. The consensus board consisted of 3 experts who were blinded to the type of needle used. The consensus board diagnoses of disease state were based on baseline medical history, EUS and cross sectional imaging of the cyst, and aspirate characteristics (i.e. aspirate color and viscosity). If the EUS-FNA diagnosis matches with the histopathology or consensus board diagnosis, then the participant will be counted as having accurate diagnosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Requiring Post EUS-FNA Patient Management</measure>
    <time_frame>30 days</time_frame>
    <description>Post EUS-FNA patient management required (clinical and/or imaging surveillance, percutaneous drainage, surgical removal).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Whose Management Decision Was Directly Influenced by the EUS Findings</measure>
    <time_frame>Procedure - 30 days after procedure</time_frame>
    <description>Patients whose Post EUS-FNA Management (clinical and/or imaging surveillance, percutaneous drainage, surgical removal) was Directly Influenced by the EUS-FNA findings.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Cross-over to Salvage Arm</measure>
    <time_frame>Procedure (Immediate)</time_frame>
    <description>In the case of inability to access the pancreatic cystic lesion or to attain complete cyst aspiration, salvage aspiration procedure should be performed. Patients randomized to 19G Flex should undergo a salvage procedure with 22G or 19G needle (needle choice at discretion of physician); patients randomized to 22G or 19G should undergo salvage procedure with 19G Flex needle.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Pancreatic Cystic Lesions</condition>
  <arm_group>
    <arm_group_label>19 G Flex Needle</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19 G Flex)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>22 G Needle</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22 G)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>19 G Needle</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19 G)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>19 G Flex Needle</intervention_name>
    <description>Fine Needle Aspiration of PCL with a 19 G Flex needle. If unsuccessful, a salvage procedure will be done with 19 G or 22 G needle.</description>
    <arm_group_label>19 G Flex Needle</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>22 G Needle</intervention_name>
    <description>Fine Needle Aspiration of PCL with a 22 G needle. If unsuccessful, a salvage procedure will be done with 19 G Flex needle.</description>
    <arm_group_label>22 G Needle</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>19 G Needle</intervention_name>
    <description>Fine Needle Aspiration of PCL with a 19 G needle. If unsuccessful, a salvage procedure will be done with 19 G Flex needle.</description>
    <arm_group_label>19 G Needle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pancreatic cystic lesion measuring 13mm or greater in largest diameter.&#xD;
&#xD;
          -  Indicated for EUS evaluation of the PCL including EUS-FNA.&#xD;
&#xD;
          -  Age 18 years of age or older.&#xD;
&#xD;
          -  Willing and able to comply with the study procedures and provide written informed&#xD;
             consent form to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cysts in which FNA is not indicated based on review by the clinician, including&#xD;
             potential concern of blood vessel location relative to the cyst.&#xD;
&#xD;
          -  Requirement for anticoagulation using clopidogril, warfarin, or other long acting&#xD;
             antiplatelet agents (with the exception of aspirin) that cannot be safely stopped&#xD;
             according to institutional guidelines.&#xD;
&#xD;
          -  Standard contraindications for EUS.&#xD;
&#xD;
          -  Known pancreatic pseudocyst.&#xD;
&#xD;
          -  Pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael B Wallace, MD,MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University Medical Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Presbyterian Hospital/Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Changhai Hospital</name>
      <address>
        <city>Shanghai</city>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asian Institute of Gastroenterology</name>
      <address>
        <city>Hyderabad</city>
        <zip>500 082</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>India</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <results_first_submitted>October 20, 2020</results_first_submitted>
  <results_first_submitted_qc>October 20, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 12, 2020</results_first_posted>
  <last_update_submitted>January 14, 2021</last_update_submitted>
  <last_update_submitted_qc>January 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pancreatic Cystic Lesions</keyword>
  <keyword>PCL</keyword>
  <keyword>EUS-FNA</keyword>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 12, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT01711294/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 31, 2012</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT01711294/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>19G Flex Needle</title>
          <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)&#xD;
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.</description>
        </group>
        <group group_id="P2">
          <title>22G Needle</title>
          <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)&#xD;
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
        </group>
        <group group_id="P3">
          <title>19G Needle</title>
          <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)&#xD;
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="121"/>
                <participants group_id="P2" count="65"/>
                <participants group_id="P3" count="64"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="121"/>
                <participants group_id="P2" count="65"/>
                <participants group_id="P3" count="64"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>19G Flex Needle</title>
          <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)&#xD;
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.</description>
        </group>
        <group group_id="B2">
          <title>22G Needle</title>
          <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)&#xD;
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
        </group>
        <group group_id="B3">
          <title>19G Needle</title>
          <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)&#xD;
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="121"/>
            <count group_id="B2" value="65"/>
            <count group_id="B3" value="64"/>
            <count group_id="B4" value="250"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="121"/>
                    <count group_id="B2" value="65"/>
                    <count group_id="B3" value="64"/>
                    <count group_id="B4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63" spread="14"/>
                    <measurement group_id="B2" value="65" spread="16"/>
                    <measurement group_id="B3" value="62" spread="15"/>
                    <measurement group_id="B4" value="63" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="121"/>
                    <count group_id="B2" value="65"/>
                    <count group_id="B3" value="64"/>
                    <count group_id="B4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="34"/>
                    <measurement group_id="B4" value="134"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Medical History</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Diabetes Mellitus</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="121"/>
                    <count group_id="B2" value="65"/>
                    <count group_id="B3" value="64"/>
                    <count group_id="B4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chronic Pancreatitis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="121"/>
                    <count group_id="B2" value="65"/>
                    <count group_id="B3" value="64"/>
                    <count group_id="B4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Necrotizing Pancreatitis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="121"/>
                    <count group_id="B2" value="65"/>
                    <count group_id="B3" value="64"/>
                    <count group_id="B4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Symptomatic</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="121"/>
                    <count group_id="B2" value="65"/>
                    <count group_id="B3" value="64"/>
                    <count group_id="B4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pancreatic Cystic Lesion (PCL) Location</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="121"/>
                    <count group_id="B2" value="65"/>
                    <count group_id="B3" value="64"/>
                    <count group_id="B4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Head/uncinate</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="109"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Body</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="70"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Tail</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Neck</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Junction of body and tail</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Volume of Aspirated Cyst Fluid as a Function of Estimated Maximal Volume</title>
        <description>Volume of aspirated cyst fluid as a function of estimated maximal volume, based on pre-aspiration EUS measure of cyst diameter (s) (% aspiration of total estimated volume)</description>
        <time_frame>At procedure (Up to 1 hour)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>19G Flex Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)&#xD;
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.</description>
          </group>
          <group group_id="O2">
            <title>22G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)&#xD;
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
          <group group_id="O3">
            <title>19G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)&#xD;
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
        </group_list>
        <measure>
          <title>Volume of Aspirated Cyst Fluid as a Function of Estimated Maximal Volume</title>
          <description>Volume of aspirated cyst fluid as a function of estimated maximal volume, based on pre-aspiration EUS measure of cyst diameter (s) (% aspiration of total estimated volume)</description>
          <units>percentage of cyst volume aspirated</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="121"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78" spread="35"/>
                    <measurement group_id="O2" value="74" spread="39"/>
                    <measurement group_id="O3" value="73" spread="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Study hypothesizes that aspiration % in the 19G Flex and 19G arms would be superior by at least 10% to 22G arm, and aspiration success rate of 19G Flex would be at least 16% greater than 22G and 19G arms. Sample size calculation was performed based on the above hypotheses reached by a consensus of all collaborators and adjusted a priori.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Sample sizes were calculated using two-sample t-test for the primary endpoint and z-test for the secondary endpoint with power of 80% and two-sided alpha of 0.05. Hochberg step up procedure was used to adjust for multiple comparison. A p-value &lt; 0.05 was considered statistically significant.</non_inferiority_desc>
            <p_value>0.84</p_value>
            <p_value_desc>Hochberg step up procedure was used to adjust for multiple comparison.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
            <method_desc>Wilcoxon was used instead of t-test because the data was not normally distributed.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Related Adverse Events</title>
        <description>Adverse events related to study procedure or study device were tabulated. Adverse events were assessed from the index procedure up to 30 days post procedure.</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>19G Flex Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)&#xD;
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.</description>
          </group>
          <group group_id="O2">
            <title>22G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)&#xD;
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
          <group group_id="O3">
            <title>19G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)&#xD;
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Related Adverse Events</title>
          <description>Adverse events related to study procedure or study device were tabulated. Adverse events were assessed from the index procedure up to 30 days post procedure.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="121"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Volume of Cyst Post Initial Procedure Compared to Pre Procedure</title>
        <description>Change value is calculated as cyst volume measured after initial procedure (up to 1 hour) minus volume measured at the beginning of the initial procedure. Volume is measured using the standard geometric formula 4/3 πr³ where r is half the long axis. The volume unit is cc.</description>
        <time_frame>Procedure (Up to 1 hour)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>19G Flex Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)&#xD;
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.</description>
          </group>
          <group group_id="O2">
            <title>22G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)&#xD;
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
          <group group_id="O3">
            <title>19G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)&#xD;
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Volume of Cyst Post Initial Procedure Compared to Pre Procedure</title>
          <description>Change value is calculated as cyst volume measured after initial procedure (up to 1 hour) minus volume measured at the beginning of the initial procedure. Volume is measured using the standard geometric formula 4/3 πr³ where r is half the long axis. The volume unit is cc.</description>
          <units>cc</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="121"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16" spread="38"/>
                    <measurement group_id="O2" value="13" spread="35"/>
                    <measurement group_id="O3" value="22" spread="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Successful Echoendoscopic Fine Needle Aspiration of PCL</title>
        <description>Successful echoendoscopic fine needle aspiration of PCL, defined as complete cyst aspiration (final cyst maximal diameter of less than 5mm) or collection of aspirate adequate to perform two standard assays: cytology and carcinoembryonic antigen (CEA) (sample volume of 3 cc or more)</description>
        <time_frame>Procedure (up to 1 hour)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>19G Flex Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)&#xD;
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.</description>
          </group>
          <group group_id="O2">
            <title>22G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)&#xD;
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
          <group group_id="O3">
            <title>19G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)&#xD;
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Successful Echoendoscopic Fine Needle Aspiration of PCL</title>
          <description>Successful echoendoscopic fine needle aspiration of PCL, defined as complete cyst aspiration (final cyst maximal diameter of less than 5mm) or collection of aspirate adequate to perform two standard assays: cytology and carcinoembryonic antigen (CEA) (sample volume of 3 cc or more)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="121"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108"/>
                    <measurement group_id="O2" value="53"/>
                    <measurement group_id="O3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With PCL Reached/Penetrated</title>
        <description>Patients whose pancreatic cyst lesion(s) can be reached and penetrated by the EUS-FNA needles.</description>
        <time_frame>Procedure (Up to 1 hour)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>19G Flex Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)&#xD;
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.</description>
          </group>
          <group group_id="O2">
            <title>22G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)&#xD;
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
          <group group_id="O3">
            <title>19G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)&#xD;
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With PCL Reached/Penetrated</title>
          <description>Patients whose pancreatic cyst lesion(s) can be reached and penetrated by the EUS-FNA needles.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="121"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114"/>
                    <measurement group_id="O2" value="62"/>
                    <measurement group_id="O3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of EUS-FNA Needle Passes at Initial Procedure.</title>
        <description>Needle pass defined as needle insertion through needle removal outside the cyst lumen, but not including needle repositioning within a single or multi-compartment cyst.</description>
        <time_frame>Procedure (Up to 1 hour)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>19G Flex Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)&#xD;
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.</description>
          </group>
          <group group_id="O2">
            <title>22G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)&#xD;
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
          <group group_id="O3">
            <title>19G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)&#xD;
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of EUS-FNA Needle Passes at Initial Procedure.</title>
          <description>Needle pass defined as needle insertion through needle removal outside the cyst lumen, but not including needle repositioning within a single or multi-compartment cyst.</description>
          <units>Needle passes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="121"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" spread="0"/>
                    <measurement group_id="O2" value="1" spread="0"/>
                    <measurement group_id="O3" value="1" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of EUS-FNA Needles Used at Initial Procedure.</title>
        <description>Total number of EUS-FNA needles used across all participants at the initial procedure.</description>
        <time_frame>Procedure (Up to 1 hour)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>19G Flex Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)&#xD;
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.</description>
          </group>
          <group group_id="O2">
            <title>22G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)&#xD;
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
          <group group_id="O3">
            <title>19G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)&#xD;
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of EUS-FNA Needles Used at Initial Procedure.</title>
          <description>Total number of EUS-FNA needles used across all participants at the initial procedure.</description>
          <units>Needles used</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="121"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="156"/>
                    <measurement group_id="O2" value="81"/>
                    <measurement group_id="O3" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time Needed for Aspiration for Each Needle Pass at Initial Procedure.</title>
        <description>Needle pass is defined as needle insertion through needle removal outside the cyst lumen, but not including needle repositioning within a single or multi-compartment cyst.&#xD;
Time of needle pass in is time of the first needle puncture into the cyst lumen. Needle pass out is time of removal of needle outside the cyst lumen, or after 10 seconds of failed attempt to aspirate fluid after the last needle re-repositioning in a single or multi-compartment cyst.</description>
        <time_frame>Procedure (Up to 1 hour)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>19G Flex Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)&#xD;
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.</description>
          </group>
          <group group_id="O2">
            <title>22G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)&#xD;
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
          <group group_id="O3">
            <title>19G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)&#xD;
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
        </group_list>
        <measure>
          <title>Time Needed for Aspiration for Each Needle Pass at Initial Procedure.</title>
          <description>Needle pass is defined as needle insertion through needle removal outside the cyst lumen, but not including needle repositioning within a single or multi-compartment cyst.&#xD;
Time of needle pass in is time of the first needle puncture into the cyst lumen. Needle pass out is time of removal of needle outside the cyst lumen, or after 10 seconds of failed attempt to aspirate fluid after the last needle re-repositioning in a single or multi-compartment cyst.</description>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="121"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86" spread="115"/>
                    <measurement group_id="O2" value="145" spread="188"/>
                    <measurement group_id="O3" value="106" spread="163"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time From First Needle Pass in to Last Needle Pass Out at Initial Procedure.</title>
        <description>Needle pass is defined as needle insertion through needle removal outside the cyst lumen, but not including needle repositioning within a single or multi-compartment cyst. Time of first needle pass in is time of the first needle puncture into the cyst lumen. Time of last needle pass out is time of removal of needle outside the cyst lumen at the end of the last fluid aspiration from a single or multi-loculated cyst, or after 10 seconds of failed attempt to aspirate fluid after the last needle re-repositioning in a single or multi-compartment cyst.</description>
        <time_frame>Procedure (Up to 1 hour)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>19G Flex Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)&#xD;
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.</description>
          </group>
          <group group_id="O2">
            <title>22G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)&#xD;
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
          <group group_id="O3">
            <title>19G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)&#xD;
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From First Needle Pass in to Last Needle Pass Out at Initial Procedure.</title>
          <description>Needle pass is defined as needle insertion through needle removal outside the cyst lumen, but not including needle repositioning within a single or multi-compartment cyst. Time of first needle pass in is time of the first needle puncture into the cyst lumen. Time of last needle pass out is time of removal of needle outside the cyst lumen at the end of the last fluid aspiration from a single or multi-loculated cyst, or after 10 seconds of failed attempt to aspirate fluid after the last needle re-repositioning in a single or multi-compartment cyst.</description>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="121"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="210" spread="225"/>
                    <measurement group_id="O2" value="198" spread="161"/>
                    <measurement group_id="O3" value="238" spread="205"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Needles With Needle Insertion Rated as Excellent/Very Good</title>
        <description>Number of needles rated either Excellent or Very good when inserted into the echoendoscope at the initial procedure.</description>
        <time_frame>Procedure (Up to 1 hour)</time_frame>
        <population>Ease of needle passage into the echoendoscope is evaluated per needle.</population>
        <group_list>
          <group group_id="O1">
            <title>19G Flex Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)&#xD;
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.</description>
          </group>
          <group group_id="O2">
            <title>22G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)&#xD;
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
          <group group_id="O3">
            <title>19G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)&#xD;
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Needles With Needle Insertion Rated as Excellent/Very Good</title>
          <description>Number of needles rated either Excellent or Very good when inserted into the echoendoscope at the initial procedure.</description>
          <population>Ease of needle passage into the echoendoscope is evaluated per needle.</population>
          <units>Needles</units>
          <param>Count of Units</param>
          <units_analyzed>Needles</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="121"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="64"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Needles</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="137"/>
                <count group_id="O2" value="72"/>
                <count group_id="O3" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                    <measurement group_id="O2" value="65"/>
                    <measurement group_id="O3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Needles With Needle Removal Rated as Excellent/Very Good</title>
        <description>Number of needles rated either Excellent or Very good when removed from the echoendoscope at the initial procedure.</description>
        <time_frame>Procedure (Up to 1 hour)</time_frame>
        <population>Ease of needle passage out of the echoendoscope is evaluated per needle.</population>
        <group_list>
          <group group_id="O1">
            <title>19G Flex Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)&#xD;
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.</description>
          </group>
          <group group_id="O2">
            <title>22G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)&#xD;
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
          <group group_id="O3">
            <title>19G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)&#xD;
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Needles With Needle Removal Rated as Excellent/Very Good</title>
          <description>Number of needles rated either Excellent or Very good when removed from the echoendoscope at the initial procedure.</description>
          <population>Ease of needle passage out of the echoendoscope is evaluated per needle.</population>
          <units>Needles</units>
          <param>Count of Units</param>
          <units_analyzed>Needles</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="121"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="64"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Needles</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="135"/>
                <count group_id="O2" value="72"/>
                <count group_id="O3" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108"/>
                    <measurement group_id="O2" value="67"/>
                    <measurement group_id="O3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Needles With Needle Visualization Rated as Excellent/Very Good</title>
        <description>Number of needles rated either Excellent or Very good for visualization at the initial procedure.</description>
        <time_frame>Procedure (Up to 1 hour)</time_frame>
        <population>Quality of needle visualization inside the cyst is evaluated per needle.</population>
        <group_list>
          <group group_id="O1">
            <title>19G Flex Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)&#xD;
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.</description>
          </group>
          <group group_id="O2">
            <title>22G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)&#xD;
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
          <group group_id="O3">
            <title>19G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)&#xD;
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Needles With Needle Visualization Rated as Excellent/Very Good</title>
          <description>Number of needles rated either Excellent or Very good for visualization at the initial procedure.</description>
          <population>Quality of needle visualization inside the cyst is evaluated per needle.</population>
          <units>Needle</units>
          <param>Count of Units</param>
          <units_analyzed>Needle</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="121"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="64"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Needle</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="69"/>
                <count group_id="O3" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                    <measurement group_id="O2" value="61"/>
                    <measurement group_id="O3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Accurate Diagnosis of the Disease State Using the EUS-FNA Needles</title>
        <description>In order to assess the accuracy of EUS-FNA-based standard assays (cytology and CEA) as a diagnostic measure of disease state, the Disease State per EUS-FNA measure was compared to a reference diagnosis. The reference diagnostic standard was diagnosis from a surgical specimen histology, the true gold standard for cases that evolved to surgical resection within the follow-up of the study. For cases that did not progress to surgery within the follow-up period, the reference diagnostic standard was a composite diagnosis by a consensus board. The consensus board consisted of 3 experts who were blinded to the type of needle used. The consensus board diagnoses of disease state were based on baseline medical history, EUS and cross sectional imaging of the cyst, and aspirate characteristics (i.e. aspirate color and viscosity). If the EUS-FNA diagnosis matches with the histopathology or consensus board diagnosis, then the participant will be counted as having accurate diagnosis.</description>
        <time_frame>up to 2 years</time_frame>
        <population>3 patients excluded from analysis population in 19G Flex Arm due to histology diagnosis of neuroendocrine tumor (1), EUS diagnosis of neuroendocrine tumor (1), and solid cystic papillary neoplasm (1). 2 patients excluded from analysis population in 22G Arm due to missing EUS diagnosis (1) and EUS diagnosis of SPEN (1). 4 patients excluded from analysis population in 19G Arm due to missing EUS diagnosis (1) and EUS diagnosis of neuroendocrine tumor (3).</population>
        <group_list>
          <group group_id="O1">
            <title>19G Flex Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)&#xD;
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.</description>
          </group>
          <group group_id="O2">
            <title>22G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)&#xD;
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
          <group group_id="O3">
            <title>19G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)&#xD;
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Accurate Diagnosis of the Disease State Using the EUS-FNA Needles</title>
          <description>In order to assess the accuracy of EUS-FNA-based standard assays (cytology and CEA) as a diagnostic measure of disease state, the Disease State per EUS-FNA measure was compared to a reference diagnosis. The reference diagnostic standard was diagnosis from a surgical specimen histology, the true gold standard for cases that evolved to surgical resection within the follow-up of the study. For cases that did not progress to surgery within the follow-up period, the reference diagnostic standard was a composite diagnosis by a consensus board. The consensus board consisted of 3 experts who were blinded to the type of needle used. The consensus board diagnoses of disease state were based on baseline medical history, EUS and cross sectional imaging of the cyst, and aspirate characteristics (i.e. aspirate color and viscosity). If the EUS-FNA diagnosis matches with the histopathology or consensus board diagnosis, then the participant will be counted as having accurate diagnosis.</description>
          <population>3 patients excluded from analysis population in 19G Flex Arm due to histology diagnosis of neuroendocrine tumor (1), EUS diagnosis of neuroendocrine tumor (1), and solid cystic papillary neoplasm (1). 2 patients excluded from analysis population in 22G Arm due to missing EUS diagnosis (1) and EUS diagnosis of SPEN (1). 4 patients excluded from analysis population in 19G Arm due to missing EUS diagnosis (1) and EUS diagnosis of neuroendocrine tumor (3).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="118"/>
                <count group_id="O2" value="63"/>
                <count group_id="O3" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91"/>
                    <measurement group_id="O2" value="50"/>
                    <measurement group_id="O3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Requiring Post EUS-FNA Patient Management</title>
        <description>Post EUS-FNA patient management required (clinical and/or imaging surveillance, percutaneous drainage, surgical removal).</description>
        <time_frame>30 days</time_frame>
        <population>3 patients excluded from this analysis (1 patient in each Arm) due to missing data in post EUS-FNA patient management.</population>
        <group_list>
          <group group_id="O1">
            <title>19G Flex Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)&#xD;
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.</description>
          </group>
          <group group_id="O2">
            <title>22G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)&#xD;
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
          <group group_id="O3">
            <title>19G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)&#xD;
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Requiring Post EUS-FNA Patient Management</title>
          <description>Post EUS-FNA patient management required (clinical and/or imaging surveillance, percutaneous drainage, surgical removal).</description>
          <population>3 patients excluded from this analysis (1 patient in each Arm) due to missing data in post EUS-FNA patient management.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="64"/>
                <count group_id="O3" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85"/>
                    <measurement group_id="O2" value="45"/>
                    <measurement group_id="O3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Whose Management Decision Was Directly Influenced by the EUS Findings</title>
        <description>Patients whose Post EUS-FNA Management (clinical and/or imaging surveillance, percutaneous drainage, surgical removal) was Directly Influenced by the EUS-FNA findings.</description>
        <time_frame>Procedure - 30 days after procedure</time_frame>
        <population>3 patients excluded from this analysis (1 patient in each Arm) due to missing data in patient management decision directly influenced by the EUS findings.</population>
        <group_list>
          <group group_id="O1">
            <title>19G Flex Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)&#xD;
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.</description>
          </group>
          <group group_id="O2">
            <title>22G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)&#xD;
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
          <group group_id="O3">
            <title>19G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)&#xD;
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Whose Management Decision Was Directly Influenced by the EUS Findings</title>
          <description>Patients whose Post EUS-FNA Management (clinical and/or imaging surveillance, percutaneous drainage, surgical removal) was Directly Influenced by the EUS-FNA findings.</description>
          <population>3 patients excluded from this analysis (1 patient in each Arm) due to missing data in patient management decision directly influenced by the EUS findings.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="64"/>
                <count group_id="O3" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106"/>
                    <measurement group_id="O2" value="56"/>
                    <measurement group_id="O3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Cross-over to Salvage Arm</title>
        <description>In the case of inability to access the pancreatic cystic lesion or to attain complete cyst aspiration, salvage aspiration procedure should be performed. Patients randomized to 19G Flex should undergo a salvage procedure with 22G or 19G needle (needle choice at discretion of physician); patients randomized to 22G or 19G should undergo salvage procedure with 19G Flex needle.</description>
        <time_frame>Procedure (Immediate)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>19G Flex Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)&#xD;
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.</description>
          </group>
          <group group_id="O2">
            <title>22G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)&#xD;
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
          <group group_id="O3">
            <title>19G Needle</title>
            <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)&#xD;
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Cross-over to Salvage Arm</title>
          <description>In the case of inability to access the pancreatic cystic lesion or to attain complete cyst aspiration, salvage aspiration procedure should be performed. Patients randomized to 19G Flex should undergo a salvage procedure with 22G or 19G needle (needle choice at discretion of physician); patients randomized to 22G or 19G should undergo salvage procedure with 19G Flex needle.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="121"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data collected from the time the participant signed to informed consent and was randomized to the study, until completion of the post-EUS FNA procedure 30-day follow-up visit (window of 25-35 days post EUS FNA procedure).</time_frame>
      <desc>Reported on all Serious Adverse Events and procedure-related non-serious Adverse Events.</desc>
      <group_list>
        <group group_id="E1">
          <title>19G Flex Needle</title>
          <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)&#xD;
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.</description>
        </group>
        <group group_id="E2">
          <title>22G Needle</title>
          <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)&#xD;
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
        </group>
        <group group_id="E3">
          <title>19G Needle</title>
          <description>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)&#xD;
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (15.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="121"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="121"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="121"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="121"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Endometrial cancer metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="121"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Neuroendocrine carcinoma metastatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="121"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="121"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (15.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="121"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="121"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="121"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Haemorrhagic cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="121"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Lina Ginnetti, Clinical Endoscopy Director</name_or_title>
      <organization>Boston Scientific Corporation</organization>
      <phone>508-683-4512</phone>
      <email>lina.ginnetti@bsci.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01711294
org study id: 90869947
secondary id: E7084
nct id: NCT01711294
lead sponsor: 
has dmc: No
To document impact of EUS-FNA needle size and flexibility on effectiveness of pancreatic
      cystic lesions (PCL) aspiration, on ability to obtain sufficient material for standard
      diagnostic testing, and on diagnostic accuracy of EUS-FNA aspirate for differentiation of
      mucinous (pre-malignant) and non-mucinous cysts.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Volume of Aspirated Cyst Fluid as a Function of Estimated Maximal Volume
time frame: At procedure (Up to 1 hour)
description: Volume of aspirated cyst fluid as a function of estimated maximal volume, based on pre-aspiration EUS measure of cyst diameter (s) (% aspiration of total estimated volume)
measure: Number of Patients With Related Adverse Events
time frame: 30 days
description: Adverse events related to study procedure or study device were tabulated. Adverse events were assessed from the index procedure up to 30 days post procedure.
measure: Change in Volume of Cyst Post Initial Procedure Compared to Pre Procedure
time frame: Procedure (Up to 1 hour)
description: Change value is calculated as cyst volume measured after initial procedure (up to 1 hour) minus volume measured at the beginning of the initial procedure. Volume is measured using the standard geometric formula 4/3 πr³ where r is half the long axis. The volume unit is cc.
measure: Number of Participants With Successful Echoendoscopic Fine Needle Aspiration of PCL
time frame: Procedure (up to 1 hour)
description: Successful echoendoscopic fine needle aspiration of PCL, defined as complete cyst aspiration (final cyst maximal diameter of less than 5mm) or collection of aspirate adequate to perform two standard assays: cytology and carcinoembryonic antigen (CEA) (sample volume of 3 cc or more)
measure: Number of Participants With PCL Reached/Penetrated
time frame: Procedure (Up to 1 hour)
description: Patients whose pancreatic cyst lesion(s) can be reached and penetrated by the EUS-FNA needles.
measure: Number of EUS-FNA Needle Passes at Initial Procedure.
time frame: Procedure (Up to 1 hour)
description: Needle pass defined as needle insertion through needle removal outside the cyst lumen, but not including needle repositioning within a single or multi-compartment cyst.
measure: Number of EUS-FNA Needles Used at Initial Procedure.
time frame: Procedure (Up to 1 hour)
description: Total number of EUS-FNA needles used across all participants at the initial procedure.
measure: Time Needed for Aspiration for Each Needle Pass at Initial Procedure.
time frame: Procedure (Up to 1 hour)
description: Needle pass is defined as needle insertion through needle removal outside the cyst lumen, but not including needle repositioning within a single or multi-compartment cyst.
Time of needle pass in is time of the first needle puncture into the cyst lumen. Needle pass out is time of removal of needle outside the cyst lumen, or after 10 seconds of failed attempt to aspirate fluid after the last needle re-repositioning in a single or multi-compartment cyst.
measure: Time From First Needle Pass in to Last Needle Pass Out at Initial Procedure.
time frame: Procedure (Up to 1 hour)
description: Needle pass is defined as needle insertion through needle removal outside the cyst lumen, but not including needle repositioning within a single or multi-compartment cyst. Time of first needle pass in is time of the first needle puncture into the cyst lumen. Time of last needle pass out is time of removal of needle outside the cyst lumen at the end of the last fluid aspiration from a single or multi-loculated cyst, or after 10 seconds of failed attempt to aspirate fluid after the last needle re-repositioning in a single or multi-compartment cyst.
measure: Number of Needles With Needle Insertion Rated as Excellent/Very Good
time frame: Procedure (Up to 1 hour)
description: Number of needles rated either Excellent or Very good when inserted into the echoendoscope at the initial procedure.
measure: Number of Needles With Needle Removal Rated as Excellent/Very Good
time frame: Procedure (Up to 1 hour)
description: Number of needles rated either Excellent or Very good when removed from the echoendoscope at the initial procedure.
measure: Number of Needles With Needle Visualization Rated as Excellent/Very Good
time frame: Procedure (Up to 1 hour)
description: Number of needles rated either Excellent or Very good for visualization at the initial procedure.
measure: Number of Participants With Accurate Diagnosis of the Disease State Using the EUS-FNA Needles
time frame: up to 2 years
description: In order to assess the accuracy of EUS-FNA-based standard assays (cytology and CEA) as a diagnostic measure of disease state, the Disease State per EUS-FNA measure was compared to a reference diagnosis. The reference diagnostic standard was diagnosis from a surgical specimen histology, the true gold standard for cases that evolved to surgical resection within the follow-up of the study. For cases that did not progress to surgery within the follow-up period, the reference diagnostic standard was a composite diagnosis by a consensus board. The consensus board consisted of 3 experts who were blinded to the type of needle used. The consensus board diagnoses of disease state were based on baseline medical history, EUS and cross sectional imaging of the cyst, and aspirate characteristics (i.e. aspirate color and viscosity). If the EUS-FNA diagnosis matches with the histopathology or consensus board diagnosis, then the participant will be counted as having accurate diagnosis.
measure: Number of Participants Requiring Post EUS-FNA Patient Management
time frame: 30 days
description: Post EUS-FNA patient management required (clinical and/or imaging surveillance, percutaneous drainage, surgical removal).
measure: Number of Participants Whose Management Decision Was Directly Influenced by the EUS Findings
time frame: Procedure - 30 days after procedure
description: Patients whose Post EUS-FNA Management (clinical and/or imaging surveillance, percutaneous drainage, surgical removal) was Directly Influenced by the EUS-FNA findings.
measure: Rate of Cross-over to Salvage Arm
time frame: Procedure (Immediate)
description: In the case of inability to access the pancreatic cystic lesion or to attain complete cyst aspiration, salvage aspiration procedure should be performed. Patients randomized to 19G Flex should undergo a salvage procedure with 22G or 19G needle (needle choice at discretion of physician); patients randomized to 22G or 19G should undergo salvage procedure with 19G Flex needle.
arm group label: 19 G Flex Needle
arm group type: Active Comparator
description: Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19 G Flex)
arm group label: 22 G Needle
arm group type: Active Comparator
description: Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22 G)
arm group label: 19 G Needle
arm group type: Active Comparator
description: Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19 G)
intervention type: Device
intervention name: 19 G Flex Needle
description: Fine Needle Aspiration of PCL with a 19 G Flex needle. If unsuccessful, a salvage procedure will be done with 19 G or 22 G needle.
arm group label: 19 G Flex Needle
intervention type: Device
intervention name: 22 G Needle
description: Fine Needle Aspiration of PCL with a 22 G needle. If unsuccessful, a salvage procedure will be done with 19 G Flex needle.
arm group label: 22 G Needle
intervention type: Device
intervention name: 19 G Needle
description: Fine Needle Aspiration of PCL with a 19 G needle. If unsuccessful, a salvage procedure will be done with 19 G Flex needle.
arm group label: 19 G Needle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael B Wallace, MD,MPH
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
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country: China
country: India
country: United States
responsible party type: Sponsor
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 