<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/NCT03032198</url>
  </required_header>
  <id_info>
    <org_study_id>Thyroid-01</org_study_id>
    <nct_id>NCT03032198</nct_id>
  </id_info>
  <brief_title>&quot;Clinical Evaluation of Opto-Acoustic Tomography for Detection and Diagnostic Differentiation of Thyroid Nodules&quot;</brief_title>
  <official_title>&quot;Early R&amp;D Clinical Evaluation of Opto-Acoustic Tomography for Detection and Diagnostic Differentiation of Thyroid Nodules&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seno Medical Instruments Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seno Medical Instruments Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Thyroid Feasibility Study&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an early R&amp;D Feasibility study to assess Imagio OA/US's ability to optimize the&#xD;
      device algorithm specific to thyroid in order to detect the difference between benign and&#xD;
      malignant thyroid nodules&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Revision to over all corporate strategy&#xD;
  </why_stopped>
  <start_date type="Actual">December 4, 2017</start_date>
  <completion_date type="Actual">April 19, 2019</completion_date>
  <primary_completion_date type="Actual">June 17, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Initial Assessment of Imagio's Ability to Distinguish Between Benign and Malignant Thyroid Nodules.</measure>
    <time_frame>12-24 months</time_frame>
    <description>The primary objective of this feasibility study is to provide an initial assessment of Imagio OA's ability to distinguish between benign and malignant thyroid nodules, and when appropriate, between benign and metastatic cervical lymph nodes in subjects.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Feasibility Study for Thyroid Indication</condition>
  <arm_group>
    <arm_group_label>Imagio OA/US Scan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Imagio opto-acoustic gray-scale ultrasound scan</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Imagio OA/US</intervention_name>
    <description>Diagnostic opto-acoustic gray-scale ultrasound</description>
    <arm_group_label>Imagio OA/US Scan</arm_group_label>
    <other_name>opto-acoustic gray-scale ultrasound</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Have been informed of the nature of the study and provided written informed consent,&#xD;
             prior to initiation of any study activities;&#xD;
&#xD;
          2. Have an undiagnosed suspicious solid or mostly solid thyroid nodule.;&#xD;
&#xD;
          3. 18 years of age or older at the time of consent;&#xD;
&#xD;
          4. Are willing and able to complete all procedures and assessments in accordance with the&#xD;
             clinical protocol; and,&#xD;
&#xD;
          5. Have received recommendation for and are scheduled for an ultrasound guided FNAB,&#xD;
             ultrasound guided core biopsy, excisional biopsy, lobectomy or complete thyroidectomy&#xD;
             of at least one thyroid nodule.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Are prisoners;&#xD;
&#xD;
          2. Have a condition or impediment (i.e., insect bites, poison ivy, open sores, chafing of&#xD;
             the skin, scar, tattoos, moles, etc.); that could interfere with the intended field of&#xD;
             view (within one probe length or 4 cm of the nodule),&#xD;
&#xD;
          3. Previous or on-going radioactive iodine treatment.&#xD;
&#xD;
          4. Nodule to be biopsied is greater than 3.0 cm in maximum diameter;&#xD;
&#xD;
          5. Is pregnant;&#xD;
&#xD;
          6. Have an acute or a chronic hematoma and/or acute ecchymosis of the thyroid;&#xD;
&#xD;
          7. Is experiencing photo-toxicity or photo-sensitivity or is undergoing treatment for a&#xD;
             photo-sensitive condition such as porphyria or lupus erythematosus;&#xD;
&#xD;
          8. Patient has received chemotherapy for any type of cancer within 90 days from date of&#xD;
             screening CDU;&#xD;
&#xD;
          9. Have had previous image guided FNAB or surgical biopsy of the target nodule of&#xD;
             interest within the 45 days of baseline Imagio Scan;&#xD;
&#xD;
         10. Patient has participated in a clinical study of an investigational drug or device&#xD;
             within 3 months prior to screening CDU that may have an impact on clinical outcomes;&#xD;
             and,&#xD;
&#xD;
         11. Patient has previously participated in this study.&#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>Tom Stavros, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seno Medical, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Invision Sally Jobe</name>
      <address>
        <city>Greenwood Village</city>
        <state>Colorado</state>
        <zip>80111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Health Science Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <results_first_submitted>March 29, 2022</results_first_submitted>
  <results_first_submitted_qc>June 17, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 13, 2022</results_first_posted>
  <last_update_submitted>July 12, 2022</last_update_submitted>
  <last_update_submitted_qc>July 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Nodule</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT03032198/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Trial was terminated early due to corporate strategy changes</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Imagio OA/US Scan</title>
          <description>Imagio opto-acoustic gray-scale ultrasound scan&#xD;
Imagio OA/US: Diagnostic opto-acoustic gray-scale ultrasound</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Screen Fail</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>36 patients under-going an Imagio exam, 1 screen failure prior to Imagio exam</population>
      <group_list>
        <group group_id="B1">
          <title>Imagio OA/US Scan</title>
          <description>Imagio opto-acoustic gray-scale ultrasound scan&#xD;
Imagio OA/US: Diagnostic opto-acoustic gray-scale ultrasound</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="37"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57" 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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Initial Assessment of Imagio's Ability to Distinguish Between Benign and Malignant Thyroid Nodules.</title>
        <description>The primary objective of this feasibility study is to provide an initial assessment of Imagio OA's ability to distinguish between benign and malignant thyroid nodules, and when appropriate, between benign and metastatic cervical lymph nodes in subjects.</description>
        <time_frame>12-24 months</time_frame>
        <population>This Early R&amp;D Development Study was terminated early due to change in corporate strategy. The study was discontinued before we initiated the independent reader portion of the study which would have been the basis for producing the data that is needed for analyzing this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Imagio OA/US Scan</title>
            <description>Imagio opto-acoustic gray-scale ultrasound scan&#xD;
Imagio OA/US: Diagnostic opto-acoustic gray-scale ultrasound</description>
          </group>
        </group_list>
        <measure>
          <title>Initial Assessment of Imagio's Ability to Distinguish Between Benign and Malignant Thyroid Nodules.</title>
          <description>The primary objective of this feasibility study is to provide an initial assessment of Imagio OA's ability to distinguish between benign and malignant thyroid nodules, and when appropriate, between benign and metastatic cervical lymph nodes in subjects.</description>
          <population>This Early R&amp;D Development Study was terminated early due to change in corporate strategy. The study was discontinued before we initiated the independent reader portion of the study which would have been the basis for producing the data that is needed for analyzing this endpoint.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs were collected during Imagio scanning at baseline</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Imagio OA/US Scan</title>
          <description>Imagio opto-acoustic gray-scale ultrasound scan&#xD;
Imagio OA/US: Diagnostic opto-acoustic gray-scale ultrasound</description>
        </group>
      </group_list>
      <serious_events>
        <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="36"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>Pain</default_vocab>
        <default_assessment>Non-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="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <description>One subject reported pain due to pressure of the OA probe related to the depth of lesion. This event was brief and resolved without treatment</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </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>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was discontinued due to change in corporate strategy. This Early R&amp;D Development Study was terminated early due to change in corporate strategy. The reader portion of the study was not initiated per the protocol, therefore was no data generated for the primary and secondary endpoints to analyze.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Shaan Schaeffer</name_or_title>
      <organization>Seno Medical, Inc.</organization>
      <phone>6106983259</phone>
      <email>sschaeffer@senomedical.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/NCT03032198
org study id: Thyroid-01
nct id: NCT03032198
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
Thyroid Feasibility Study
This is an early R&D Feasibility study to assess Imagio OA/US's ability to optimize the
      device algorithm specific to thyroid in order to detect the difference between benign and
      malignant thyroid nodules
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Initial Assessment of Imagio's Ability to Distinguish Between Benign and Malignant Thyroid Nodules.
time frame: 12-24 months
description: The primary objective of this feasibility study is to provide an initial assessment of Imagio OA's ability to distinguish between benign and malignant thyroid nodules, and when appropriate, between benign and metastatic cervical lymph nodes in subjects.
arm group label: Imagio OA/US Scan
arm group type: Experimental
description: Imagio opto-acoustic gray-scale ultrasound scan
intervention type: Device
intervention name: Imagio OA/US
description: Diagnostic opto-acoustic gray-scale ultrasound
arm group label: Imagio OA/US Scan
other name: opto-acoustic gray-scale ultrasound
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tom Stavros, MD
role: Principal Investigator
affiliation: Seno Medical, Inc.
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Thyroid Nodule
mesh term: Thyroid Diseases
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was discontinued due to change in corporate strategy. This Early R&D Development Study was terminated early due to change in corporate strategy. The reader portion of the study was not initiated per the protocol, therefore was no data generated for the primary and secondary endpoints to analyze.
point of contact: 