<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/NCT02205307</url>
  </required_header>
  <id_info>
    <org_study_id>PP PLR 03</org_study_id>
    <nct_id>NCT02205307</nct_id>
  </id_info>
  <brief_title>A Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection</brief_title>
  <acronym>PILLAR III</acronym>
  <official_title>A Randomized, Controlled, Parallel, Multicenter Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novadaq Technologies ULC, now a part of Stryker</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novadaq Technologies ULC, now a part of Stryker</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, controlled, parallel, multicenter study to determine the difference in&#xD;
      post-operative anastomotic leak rate in low anterior resection procedures where colon and&#xD;
      rectal tissue perfusion is evaluated using PINPOINT as an adjunct to standard surgical&#xD;
      practice compared to surgical procedures performed according to standard surgical practice&#xD;
      alone.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow recruitment&#xD;
  </why_stopped>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anastomotic Leak Rate</measure>
    <time_frame>Day 0 to Week 8 (+/- 2 weeks)</time_frame>
    <description>Anastomotic leak rate in low anterior resection procedures where colon and rectal tissue perfusion is evaluated using PINPOINT Endoscopic Fluorescence imaging or SPY Elite imaging as an adjunct to standard surgical practice compared to surgical procedures performed according to standard surgical practice alone.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of SPY Visualization and Tissue Perfusion</measure>
    <time_frame>Day 0 (Day of Surgery)</time_frame>
    <description>The ability of PINPOINT or SPY Elite to provide sufficient visualization for assessment of blood flow and related tissue perfusion during the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Post-Operative Abscess Requiring Surgical Management</measure>
    <time_frame>Day 0 to Week 8 (+/- 2 weeks)</time_frame>
    <description>Rate of postoperative abscess requiring surgical management.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">347</enrollment>
  <condition>Rectal Cancer</condition>
  <condition>Rectosigmoid Cancer</condition>
  <arm_group>
    <arm_group_label>PINPOINT or SPY Elite</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A low anterior resection will be performed according to the surgeon's standard practice with the addition of intraoperative imaging using PINPOINT near infrared fluorescence imaging or SPY Elite intraoperative imaging to assess colon and rectal tissue perfusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>STANDARD</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>A low anterior resection will be performed according to the surgeon's standard practice</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PINPOINT</intervention_name>
    <arm_group_label>PINPOINT or SPY Elite</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SPY Elite</intervention_name>
    <arm_group_label>PINPOINT or SPY Elite</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be 18 years of age or older.&#xD;
&#xD;
          -  Be undergoing open, or minimally invasive LAR for the treatment of a rectal or&#xD;
             rectosigmoid neoplasm (Subjects with rectal or rectosigmoid neoplasm(s) may be treated&#xD;
             with or without neoadjuvant therapy. Long-course neoadjuvant therapy must have been&#xD;
             completed ≥6 weeks prior to LAR surgery (Day 0).&#xD;
&#xD;
          -  Have a planned low circular stapled or transanally hand sewn anastomosis ≤10 cm from&#xD;
             the anal verge.&#xD;
&#xD;
          -  Have a colorectal or coloanal reconstruction with or without reservoir/pouch.&#xD;
&#xD;
          -  Subjects who are women of child-bearing potential must not be pregnant or lactating,&#xD;
             must have a negative pregnancy test at Day 0.&#xD;
&#xD;
          -  Have signed an approved informed consent form for the study.&#xD;
&#xD;
          -  Be willing to comply with the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Undergoing stapled anastomosis with the use of an experimental or non-FDA approved&#xD;
             stapler.&#xD;
&#xD;
          -  Undergoing ileoanal reconstruction, total colectomy or proctocolectomy,&#xD;
             abdominoperineal resection, Hartmann's procedure, Hartmann's reversal or multiple&#xD;
             synchronous colon resections (e.g., LAR and concomitant right colectomy).&#xD;
&#xD;
          -  Has received and completed a course of pelvic radiotherapy ≥ 6 months prior to LAR&#xD;
             surgery (Day 0).&#xD;
&#xD;
          -  Has previously undergone a left sided colon resection.&#xD;
&#xD;
          -  Has previously undergone a rectal resection.&#xD;
&#xD;
          -  Has recurrent rectal or rectosigmoid cancer.&#xD;
&#xD;
          -  Has a diagnosis of locally advanced rectal or rectosigmoid cancer undergoing extended&#xD;
             en bloc operations.&#xD;
&#xD;
          -  Has a diagnosis of Stage IV rectal or rectosigmoid cancer with any multifocal&#xD;
             metastases or single site metastasis with tumor size of &gt; 2 cm (Intraoperative&#xD;
             incidental finding or preoperative suspicion of Stage IV cancer with isolated (single&#xD;
             site) metastasis (≤ 2 cm) or limited metastases (≤3), with largest lesion ≤ 2 cm in&#xD;
             size, does not exclude the subject).&#xD;
&#xD;
          -  Has a diagnosis of inflammatory bowel disease (IBD). Subjects with rectal or&#xD;
             rectosigmoid cancer neoplasms and IBD are excluded.&#xD;
&#xD;
          -  Has hepatic dysfunction defined as Model for End-Stage Liver Disease (MELD) Score &gt;12.&#xD;
&#xD;
          -  Renal dysfunction defined as creatinine ≥ 2.0 mg/dL.&#xD;
&#xD;
          -  Has known allergy or history of adverse reaction to ICG, iodine or iodine dyes.&#xD;
&#xD;
          -  Has, in the Investigator's opinion, any medical condition that makes the subject a&#xD;
             poor candidate for the investigational procedure, or interferes with the&#xD;
             interpretation of study results.&#xD;
&#xD;
          -  Is actively participating in another investigational clinical study which, in the&#xD;
             Investigator's or Sponsor's opinion, would interfere 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>Michael J Stamos, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Irvine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Steven Wexner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cleveland Clinic Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>John Muir Medical Center, Concord Campus</name>
      <address>
        <city>Concord</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, Irvine</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic - Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Florida</name>
      <address>
        <city>Weston</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Clinic</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barnes Jewish Medical Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunrise Hospital and Medical Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Beth Israel</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Christ Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Cleveland Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor University Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <results_first_submitted>May 11, 2020</results_first_submitted>
  <results_first_submitted_qc>June 22, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 24, 2020</results_first_posted>
  <last_update_submitted>June 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rectal cancer</keyword>
  <keyword>Rectal neoplasm</keyword>
  <keyword>Colorectal surgery</keyword>
  <keyword>Anastomosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</mesh_term>
  </condition_browse>
  <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>April 15, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT02205307/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>April 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT02205307/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>PINPOINT or SPY Elite</title>
          <description>A low anterior resection will be performed according to the surgeon's standard practice with the addition of intraoperative imaging using PINPOINT near infrared fluorescence imaging or SPY Elite intraoperative imaging to assess colon and rectal tissue perfusion</description>
        </group>
        <group group_id="P2">
          <title>STANDARD</title>
          <description>A low anterior resection will be performed according to the surgeon's standard practice</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="178"/>
                <participants group_id="P2" count="169"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="161"/>
                <participants group_id="P2" count="163"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>PINPOINT or SPY Elite</title>
          <description>A low anterior resection will be performed according to the surgeon's standard practice with the addition of intraoperative imaging using PINPOINT near infrared fluorescence imaging or SPY Elite intraoperative imaging to assess colon and rectal tissue perfusion</description>
        </group>
        <group group_id="B2">
          <title>STANDARD</title>
          <description>A low anterior resection will be performed according to the surgeon's standard practice</description>
        </group>
        <group group_id="B3">
          <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="178"/>
            <count group_id="B2" value="169"/>
            <count group_id="B3" value="347"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Mean</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.2" spread="11.14"/>
                    <measurement group_id="B2" value="56.5" spread="11.59"/>
                    <measurement group_id="B3" value="56.9" spread="11.36"/>
                  </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="69"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="139"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="109"/>
                    <measurement group_id="B2" value="99"/>
                    <measurement group_id="B3" value="208"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race/Ethnicity</title>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="123"/>
                    <measurement group_id="B2" value="122"/>
                    <measurement group_id="B3" value="245"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="171.89" spread="9.814"/>
                    <measurement group_id="B2" value="171.32" spread="9.790"/>
                    <measurement group_id="B3" value="171.61" spread="9.792"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="82.49" spread="19.743"/>
                    <measurement group_id="B2" value="83.11" spread="19.815"/>
                    <measurement group_id="B3" value="82.79" spread="19.752"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="83"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="126"/>
                    <measurement group_id="B2" value="138"/>
                    <measurement group_id="B3" value="264"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Alcohol Consumption</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="81"/>
                    <measurement group_id="B2" value="80"/>
                    <measurement group_id="B3" value="161"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="97"/>
                    <measurement group_id="B2" value="89"/>
                    <measurement group_id="B3" value="186"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>MELD Score (Model for End-Stage Liver Disease)</title>
          <description>The Model for End-Stage Liver Disease (MELD) consists of serum bilirubin, creatinine levels, International Normalized Ratio (INR) for prothrombin time, and Serum Sodium levels. Subjects with hepatic dysfunction defined as Model for End-Stage Liver Disease (MELD) Score &gt;12 were excluded from the study. The MELD score can range from 6 to 40 with higher numbers indicating more severe disease.</description>
          <units>units on a scale (6-40)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.8" spread="1.06"/>
                    <measurement group_id="B2" value="6.7" spread="1.36"/>
                    <measurement group_id="B3" value="6.8" spread="1.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Long-Course Neoadjuvant Therapy</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="113"/>
                    <measurement group_id="B2" value="111"/>
                    <measurement group_id="B3" value="224"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pre-Operative Diagnosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Rectal Cancer</title>
                  <measurement_list>
                    <measurement group_id="B1" value="144"/>
                    <measurement group_id="B2" value="143"/>
                    <measurement group_id="B3" value="287"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Rectosigmoid Cancer</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Polyp</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Anastomotic Leak Rate</title>
        <description>Anastomotic leak rate in low anterior resection procedures where colon and rectal tissue perfusion is evaluated using PINPOINT Endoscopic Fluorescence imaging or SPY Elite imaging as an adjunct to standard surgical practice compared to surgical procedures performed according to standard surgical practice alone.</description>
        <time_frame>Day 0 to Week 8 (+/- 2 weeks)</time_frame>
        <population>Modified Intent-to-Treat (mITT): the mITT analysis population includes all randomized subjects in whom a low anterior resection surgical procedure is initiated or at least one injection with ICG was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PINPOINT or SPY Elite</title>
            <description>A low anterior resection will be performed according to the surgeon's standard practice with the addition of intraoperative imaging using PINPOINT near infrared fluorescence imaging or SPY Elite intraoperative imaging to assess colon and rectal tissue perfusion</description>
          </group>
          <group group_id="O2">
            <title>STANDARD</title>
            <description>A low anterior resection will be performed according to the surgeon's standard practice</description>
          </group>
        </group_list>
        <measure>
          <title>Anastomotic Leak Rate</title>
          <description>Anastomotic leak rate in low anterior resection procedures where colon and rectal tissue perfusion is evaluated using PINPOINT Endoscopic Fluorescence imaging or SPY Elite imaging as an adjunct to standard surgical practice compared to surgical procedures performed according to standard surgical practice alone.</description>
          <population>Modified Intent-to-Treat (mITT): the mITT analysis population includes all randomized subjects in whom a low anterior resection surgical procedure is initiated or at least one injection with ICG was performed.</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="175"/>
                <count group_id="O2" value="168"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Subjects with Post-Operative Anastomotic Leak</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Subjects Known to be Anastomotic Leak Free</title>
                  <measurement_list>
                    <measurement group_id="O1" value="148"/>
                    <measurement group_id="O2" value="148"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown/Lost to Follow Up</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of SPY Visualization and Tissue Perfusion</title>
        <description>The ability of PINPOINT or SPY Elite to provide sufficient visualization for assessment of blood flow and related tissue perfusion during the procedure</description>
        <time_frame>Day 0 (Day of Surgery)</time_frame>
        <population>Modified Intent-to-Treat (mITT): the mITT analysis population includes all randomized subjects in whom a low anterior resection surgical procedure is initiated or at least one injection with ICG was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PINPOINT or SPY Elite</title>
            <description>A low anterior resection will be performed according to the surgeon's standard practice with the addition of intraoperative imaging using PINPOINT near infrared fluorescence imaging or SPY Elite intraoperative imaging to assess colon and rectal tissue perfusion</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of SPY Visualization and Tissue Perfusion</title>
          <description>The ability of PINPOINT or SPY Elite to provide sufficient visualization for assessment of blood flow and related tissue perfusion during the procedure</description>
          <population>Modified Intent-to-Treat (mITT): the mITT analysis population includes all randomized subjects in whom a low anterior resection surgical procedure is initiated or at least one injection with ICG was performed.</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="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="167"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Post-Operative Abscess Requiring Surgical Management</title>
        <description>Rate of postoperative abscess requiring surgical management.</description>
        <time_frame>Day 0 to Week 8 (+/- 2 weeks)</time_frame>
        <population>Modified Intent-to-Treat (mITT): the mITT analysis population includes all randomized subjects in whom a low anterior resection surgical procedure is initiated or at least one injection with ICG was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>PINPOINT or SPY Elite</title>
            <description>A low anterior resection will be performed according to the surgeon's standard practice with the addition of intraoperative imaging using PINPOINT near infrared fluorescence imaging or SPY Elite intraoperative imaging to assess colon and rectal tissue perfusion</description>
          </group>
          <group group_id="O2">
            <title>STANDARD</title>
            <description>A low anterior resection will be performed according to the surgeon's standard practice</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Post-Operative Abscess Requiring Surgical Management</title>
          <description>Rate of postoperative abscess requiring surgical management.</description>
          <population>Modified Intent-to-Treat (mITT): the mITT analysis population includes all randomized subjects in whom a low anterior resection surgical procedure is initiated or at least one injection with ICG was performed.</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="175"/>
                <count group_id="O2" value="168"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="165"/>
                    <measurement group_id="O2" value="161"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>8 weeks</time_frame>
      <desc>Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.</desc>
      <group_list>
        <group group_id="E1">
          <title>PINPOINT or SPY Elite</title>
          <description>A low anterior resection will be performed according to the surgeon's standard practice with the addition of intraoperative imaging using PINPOINT near infrared fluorescence imaging or SPY Elite intraoperative imaging to assess colon and rectal tissue perfusion</description>
        </group>
        <group group_id="E2">
          <title>STANDARD</title>
          <description>A low anterior resection will be performed according to the surgeon's standard practice</description>
        </group>
        <group group_id="E3">
          <title>Not Treated</title>
          <description>Not treated by either perfusion (PINPOINT/SPY Elite) or standard treatment.</description>
        </group>
      </group_list>
      <serious_events>
        <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="3" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="52" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Cardiac Failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Small Intestinal Obstruction</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Intestinal Obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Proctalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Rectal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Abdominal Distension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Functional Gastrointestinal Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Motility Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Internal Hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Intra-Abdominal Hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Pancreatitis Acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Multi-organ Failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pelvic Abscess</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Abdominal Abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Postoperative Wound Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Septic Shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Anastomotic Leak</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Postoperative Ileus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Anastomotic Leak</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Stoma Complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Anastomotic Complication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Incision Site Erosion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Procedural Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Procedural Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Stoma Site Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Ureteric Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Wound Dehiscence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Compartment Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Alcohol Withdrawal Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Kidney Injury</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Renal Impairment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Pelvic Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Pelvic Fluid Collection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory Distress</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Ileostomy Closure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Small Intestinal Resection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Arterial Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <description>Adverse Device Effect - classified as mild, suspected to be related to PINPOINT/ICG but not to the surgical procedure itself, was assessed as Grade II and resolved.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <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="155" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="146" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="41" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Abdominal Distension</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Procedural Pain</sub_title>
                <counts group_id="E1" subjects_affected="62" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="62" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Anastomotic Leak</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Stoma Complication</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="168"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </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 NOT 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 interpretation of the efficacy results is limited due to the fact that the study was stopped early, which may have adversely affected the statistical power of some tests.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Alicia Wilton</name_or_title>
      <organization>Novadaq Technologies</organization>
      <phone>416-949-4992</phone>
      <email>alicia.wilton@stryker.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/NCT02205307
org study id: PP PLR 03
nct id: NCT02205307
lead sponsor: 
has dmc: Yes
This is a randomized, controlled, parallel, multicenter study to determine the difference in
      post-operative anastomotic leak rate in low anterior resection procedures where colon and
      rectal tissue perfusion is evaluated using PINPOINT as an adjunct to standard surgical
      practice compared to surgical procedures performed according to standard surgical practice
      alone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Anastomotic Leak Rate
time frame: Day 0 to Week 8 (+/- 2 weeks)
description: Anastomotic leak rate in low anterior resection procedures where colon and rectal tissue perfusion is evaluated using PINPOINT Endoscopic Fluorescence imaging or SPY Elite imaging as an adjunct to standard surgical practice compared to surgical procedures performed according to standard surgical practice alone.
measure: Rate of SPY Visualization and Tissue Perfusion
time frame: Day 0 (Day of Surgery)
description: The ability of PINPOINT or SPY Elite to provide sufficient visualization for assessment of blood flow and related tissue perfusion during the procedure
measure: Incidence of Post-Operative Abscess Requiring Surgical Management
time frame: Day 0 to Week 8 (+/- 2 weeks)
description: Rate of postoperative abscess requiring surgical management.
arm group label: PINPOINT or SPY Elite
arm group type: Experimental
description: A low anterior resection will be performed according to the surgeon's standard practice with the addition of intraoperative imaging using PINPOINT near infrared fluorescence imaging or SPY Elite intraoperative imaging to assess colon and rectal tissue perfusion
arm group label: STANDARD
arm group type: No Intervention
description: A low anterior resection will be performed according to the surgeon's standard practice
intervention type: Device
intervention name: PINPOINT
arm group label: PINPOINT or SPY Elite
intervention type: Device
intervention name: SPY Elite
arm group label: PINPOINT or SPY Elite
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael J Stamos, MD
role: Principal Investigator
affiliation: University of California, Irvine
last name: Steven Wexner, MD
role: Principal Investigator
affiliation: Cleveland Clinic Florida
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country: United States
responsible party type: Sponsor
mesh term: Rectal Neoplasms
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The interpretation of the efficacy results is limited due to the fact that the study was stopped early, which may have adversely affected the statistical power of some tests.
point of contact: 