<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/NCT01717014</url>
  </required_header>
  <id_info>
    <org_study_id>COVLARO0286</org_study_id>
    <nct_id>NCT01717014</nct_id>
  </id_info>
  <brief_title>Radial Reload Open LAR Case Series</brief_title>
  <official_title>Evaluating the Radial Reload Stapler With Tri-Staple TM Technology During Open Low Anterior Resection for Rectal Cancer: A Prospective Multicenter Case Series</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic - MITG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Providence Medical Research Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of South Florida</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medtronic - MITG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to evaluate the safety and feasibility of the Radial&#xD;
      Reload Stapler during open LAR for rectal cancer. The surgeon will complete questionnaires&#xD;
      relating to the function of the device.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Staple Line</measure>
    <time_frame>Operative</time_frame>
    <description>The surgeons ability to achieve a staple line at the desired level of the rectum.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distal Margins</measure>
    <time_frame>Operative</time_frame>
    <description>The ability to achieve adequate distal margins (defined as &gt;2cm [or &gt;1cm with clear histologic evaluation]) in the low rectum.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Usability: Visibility</measure>
    <time_frame>Operatively</time_frame>
    <description>Visibility measured by surgeon usability questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usability: Access</measure>
    <time_frame>Operatively</time_frame>
    <description>Access measured by surgeon usability questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usability: Manueverability</measure>
    <time_frame>Operatively</time_frame>
    <description>Manueverability measured by surgeon usability questionnaire. Question: Maneuverability of Radial reload during the procedure was adequate</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Low Anterior Resection</condition>
  <condition>Proctosigmoid Resection</condition>
  <condition>Rectal Cancer</condition>
  <arm_group>
    <arm_group_label>Covidien Radial Reload Stapler with Tri-Staple Technology</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Covidien Radial Reload Stapler with Tri-Staple Technology</intervention_name>
    <description>Case series of patients already selected to undergo an open LAR or proctosigmoidectomy using the Radial Reload Stapler</description>
    <arm_group_label>Covidien Radial Reload Stapler with Tri-Staple Technology</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The subject is able to understand and sign Informed Consent Form.&#xD;
&#xD;
          2. The subject is between 18-85 years of age.&#xD;
&#xD;
          3. The subject is anticipated to undergo a resection of the rectum with anastomosis below&#xD;
             the peritoneal reflection for the treatment of rectal cancer.&#xD;
&#xD;
          4. The subject is anticipated to undergo mobilization and stapling of the rectum through&#xD;
             an open incision.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any female patient, who is pregnant, suspected pregnant, or nursing.&#xD;
&#xD;
          2. The participant is unable or unwilling to comply with the study requirements,&#xD;
             follow-up schedule.&#xD;
&#xD;
          3. The participant has co-morbidities which, in the opinion of the investigator, will not&#xD;
             be appropriate for the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of South Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Medical Center</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <results_first_submitted>February 13, 2015</results_first_submitted>
  <results_first_submitted_qc>February 13, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 2, 2015</results_first_posted>
  <last_update_submitted>February 13, 2015</last_update_submitted>
  <last_update_submitted_qc>February 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>rectal cancer</keyword>
  <keyword>stapler</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Covidien Radial Reload Stapler With Tri-Staple Technology</title>
          <description>Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Covidien Radial Reload Stapler With Tri-Staple Technology</title>
          <description>Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.6" spread="14.8"/>
                  </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="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </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="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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>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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </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>Height</title>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="175.1" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kilograms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="88.7" spread="18.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.0" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Staple Line</title>
        <description>The surgeons ability to achieve a staple line at the desired level of the rectum.</description>
        <time_frame>Operative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Covidien Radial Reload Stapler With Tri-Staple Technology</title>
            <description>Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Staple Line</title>
          <description>The surgeons ability to achieve a staple line at the desired level of the rectum.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Distal Margins</title>
        <description>The ability to achieve adequate distal margins (defined as &gt;2cm [or &gt;1cm with clear histologic evaluation]) in the low rectum.</description>
        <time_frame>Operative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Covidien Radial Reload Stapler With Tri-Staple Technology</title>
            <description>Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Distal Margins</title>
          <description>The ability to achieve adequate distal margins (defined as &gt;2cm [or &gt;1cm with clear histologic evaluation]) in the low rectum.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Usability: Visibility</title>
        <description>Visibility measured by surgeon usability questionnaire.</description>
        <time_frame>Operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Covidien Radial Reload Stapler With Tri-Staple Technology</title>
            <description>Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Usability: Visibility</title>
          <description>Visibility measured by surgeon usability questionnaire.</description>
          <units>% of cases surgeon agree/strongly agree</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visibility adequate when RR was used operatively</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Did instrument impede visibility</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Usability: Access</title>
        <description>Access measured by surgeon usability questionnaire</description>
        <time_frame>Operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Covidien Radial Reload Stapler With Tri-Staple Technology</title>
            <description>Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Usability: Access</title>
          <description>Access measured by surgeon usability questionnaire</description>
          <units>% of cases surgeon agree/strongly agree</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Radial Reload (RR) easy to place in pelvis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RR was able to get low in pelvis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RR was easy to place in the colon &amp; rectum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Was rectum contained in the device after clamping</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RR retained an adequate tissue during clamping</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Was the rectum transected in one firing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Usability: Manueverability</title>
        <description>Manueverability measured by surgeon usability questionnaire. Question: Maneuverability of Radial reload during the procedure was adequate</description>
        <time_frame>Operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Covidien Radial Reload Stapler With Tri-Staple Technology</title>
            <description>Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Usability: Manueverability</title>
          <description>Manueverability measured by surgeon usability questionnaire. Question: Maneuverability of Radial reload during the procedure was adequate</description>
          <units>% of cases surgeon agree/strongly agree</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected through the 30 day follow-up visit</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Covidien Radial Reload Stapler With Tri-Staple Technology</title>
          <description>Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 14.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" 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" events="2" subjects_affected="2" 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" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Perirectal abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure acute</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 14.1</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="2" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Post-operative ileus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" 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>
    <point_of_contact>
      <name_or_title>Julie Doyle</name_or_title>
      <organization>Covidien</organization>
      <phone>781-839-1729</phone>
      <email>Julie.Doyle@Covidien.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/NCT01717014
org study id: COVLARO0286
nct id: NCT01717014
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this research study is to evaluate the safety and feasibility of the Radial
      Reload Stapler during open LAR for rectal cancer. The surgeon will complete questionnaires
      relating to the function of the device.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Staple Line
time frame: Operative
description: The surgeons ability to achieve a staple line at the desired level of the rectum.
measure: Distal Margins
time frame: Operative
description: The ability to achieve adequate distal margins (defined as >2cm [or >1cm with clear histologic evaluation]) in the low rectum.
measure: Usability: Visibility
time frame: Operatively
description: Visibility measured by surgeon usability questionnaire.
measure: Usability: Access
time frame: Operatively
description: Access measured by surgeon usability questionnaire
measure: Usability: Manueverability
time frame: Operatively
description: Manueverability measured by surgeon usability questionnaire. Question: Maneuverability of Radial reload during the procedure was adequate
arm group label: Covidien Radial Reload Stapler with Tri-Staple Technology
arm group type: Experimental
description: Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
intervention type: Device
intervention name: Covidien Radial Reload Stapler with Tri-Staple Technology
description: Case series of patients already selected to undergo an open LAR or proctosigmoidectomy using the Radial Reload Stapler
arm group label: Covidien Radial Reload Stapler with Tri-Staple Technology
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Rectal Neoplasms
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 