<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/NCT02189161</url>
  </required_header>
  <id_info>
    <org_study_id>B-253</org_study_id>
    <nct_id>NCT02189161</nct_id>
  </id_info>
  <brief_title>A Safety and Tolerability of Circumferential Anal Canal Radiofrequency Ablation For Anal Intraepithelial Neoplasia</brief_title>
  <official_title>A Safety and Tolerability Trial of Circumferential Anal Canal Radiofrequency Ablation For Anal Intraepithelial Neoplasia Using the Barrx™ Ablation System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic - MITG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic - MITG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assess the safety, feasibility, and patient tolerability of circumferential radiofrequency&#xD;
      ablation (RFA) to the anal canal for patients with anal intraepithelial neoplasia (AIN).&#xD;
      Patients will have AIN with high grade squamous intraepithelial lesions (HSIL) and the RFA&#xD;
      will be applied using the Barrx™ Ablation System.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</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>Related Adverse Events</measure>
    <time_frame>Within 12 months post RFA</time_frame>
    <description>Adverse event : Device relationship - Definite, Probable, Possible</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subject Tolerability: Post -Ablation Anal Pain</measure>
    <time_frame>within 4 weeks post RFA</time_frame>
    <description>Median post-ablation anal pain from 10 patients' survey after RFA treatment. Anal pain scale range: 0-10 (minimum pain=0, maximum pain=10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Assessment: Subject Score for Worry About Anal Canal Condition</measure>
    <time_frame>0-2 weeks Prior RFA and after 9-12 months post RFA</time_frame>
    <description>Median from subject scores for worry about anal canal condition at 0-2 weeks prior to RFA treatment and after 9-12 months post RFA. Median scale range: 0-10 (minimum concern=0, maximum concern=10)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Anal Intraepithelial Neoplasia (AIN)</condition>
  <condition>High-grade Squamous Intraepithelial Lesions (HSIL)</condition>
  <arm_group>
    <arm_group_label>Radiofrequency Ablation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>circumferential radiofrequency ablation (RFA) to the anal canal</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Radiofrequency Ablation (Barrx™)</intervention_name>
    <description>Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2.</description>
    <arm_group_label>Radiofrequency Ablation</arm_group_label>
    <other_name>Barrx™ Ablation System</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        Candidates for this study must meet all of the following criteria:&#xD;
&#xD;
          1. Age 18-75 years&#xD;
&#xD;
          2. HRA 2 to 8 weeks prior to the 0 month RFA visit yielding one or more flat,&#xD;
             non-condylomatous biopsy-proven HSILs that are&#xD;
&#xD;
               -  Located entirely within the eligible treatment zone AND&#xD;
&#xD;
               -  Contiguous with the squamocolumnar junction&#xD;
&#xD;
          3. Eligible treatment zone (ETZ) is defined as&#xD;
&#xD;
               -  3 cm above the dentate line to the anocutaneous line AND&#xD;
&#xD;
               -  Full anorectal circumference&#xD;
&#xD;
          4. If female of child-bearing age, negative pregnancy test within 8 weeks of the 0 month&#xD;
             RFA visit and declared intent to remain on birth control throughout the trial, or&#xD;
             declaration of infertility defined as subject report of status as post-menopausal or&#xD;
             surgically sterile (status post hysterectomy or tubal ligation).&#xD;
&#xD;
          5. If HIV positive&#xD;
&#xD;
               -  HIV positive on antiretroviral therapy for at least 3 months with laboratory&#xD;
                  blood work within 12 weeks prior to the 0 month visit demonstrating viral load &lt;&#xD;
                  50&#xD;
&#xD;
               -  CD4 count ≥ 250/mm3&#xD;
&#xD;
               -  ANC &gt; 750/mm3&#xD;
&#xD;
               -  Platelet count ≥ 75,000/mm3&#xD;
&#xD;
               -  Hemoglobin ≥ 9.0 g/dl&#xD;
&#xD;
               -  INR and PTT normal&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
        Candidates will be ineligible for enrollment in the study if any of the following&#xD;
        conditions apply:&#xD;
&#xD;
          1. Any biopsy-proven HSIL partially outside of the ETZ (for example, an HSIL lesion with&#xD;
             extension to the perianal skin)&#xD;
&#xD;
          2. Any condylomas in the eligible treatment zone &gt; 1/2 cm diameter&#xD;
&#xD;
             • Note: Condylomas in the eligible treatment zone &lt; 1/2 cm in diameter must be excised&#xD;
             or cauterized (not treated topically) before or during Visit 1 (0 month RFA visit)&#xD;
&#xD;
          3. Any anal or rectal pathology requiring treatment including ulcer, fistula, fissure, or&#xD;
             proctitis&#xD;
&#xD;
          4. Any anal stricture or stenosis in patient history or upon examination.&#xD;
&#xD;
          5. Symptomatic scarring in anal canal (i.e. not pliable, hyperkeratosis)&#xD;
&#xD;
          6. History of or present anal or rectal cancer&#xD;
&#xD;
          7. History of pelvic radiation therapy&#xD;
&#xD;
          8. History of HPV vaccination or plans to initiate HPV vaccination during the trial&#xD;
&#xD;
          9. History of ablation or resection therapy within the ETZ within 6 months prior to the 0&#xD;
             month RFA visit (other than cauterization or excision of condyloma(s))&#xD;
&#xD;
         10. Prior ablation or resection therapy consisting of ≥ 75% circumference within the ETZ&#xD;
             of anal canal.&#xD;
&#xD;
         11. History of topical therapy (e.g. Imiquimod, 5-FU, Trichloroacetic acid) within the ETZ&#xD;
             within 3 months prior to the 0 month RFA visit&#xD;
&#xD;
         12. Hemorrhoids &gt; grade III&#xD;
&#xD;
         13. Fecal incontinence&#xD;
&#xD;
         14. Concurrent disease requiring systemic immunosuppression therapy&#xD;
&#xD;
         15. Concurrent malignancy requiring systemic therapy&#xD;
&#xD;
         16. Life expectancy &lt; 2 years&#xD;
&#xD;
         17. Subject is on a platelet inhibiting agent (i.e. Aspirin, Clopidogrel, NSAIDS) and/or&#xD;
             anti-thrombotic agent (Heparin, Warfarin) and unable to discontinue 7 days before and&#xD;
             after treatment for 14 days total.&#xD;
&#xD;
               -  Exception: Aspirin 81 mg PO daily does not need to be discontinued&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Laser Surgery Care</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <results_first_submitted>April 26, 2016</results_first_submitted>
  <results_first_submitted_qc>June 3, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 14, 2016</results_first_posted>
  <last_update_submitted>June 3, 2016</last_update_submitted>
  <last_update_submitted_qc>June 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>anal intraepithelial neoplasia</keyword>
  <keyword>AIN</keyword>
  <keyword>Radiofrequency Ablation</keyword>
  <keyword>RFA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Carcinoma in Situ</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Radiofrequency Ablation</title>
          <description>circumferential radiofrequency ablation (RFA) to the anal canal&#xD;
Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </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>
      <population>subjects who have biopsy-proven HSIL and are HIV-negative or HIV-positive.</population>
      <group_list>
        <group group_id="B1">
          <title>Radiofrequency Ablation</title>
          <description>circumferential radiofrequency ablation (RFA) to the anal canal&#xD;
Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </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="51.5" spread="12.35"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Related Adverse Events</title>
        <description>Adverse event : Device relationship - Definite, Probable, Possible</description>
        <time_frame>Within 12 months post RFA</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Radiofrequency Ablation</title>
            <description>circumferential radiofrequency ablation (RFA) to the anal canal&#xD;
Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2.</description>
          </group>
        </group_list>
        <measure>
          <title>Related Adverse Events</title>
          <description>Adverse event : Device relationship - Definite, Probable, Possible</description>
          <units>number of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Definite</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Probable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Tolerability: Post -Ablation Anal Pain</title>
        <description>Median post-ablation anal pain from 10 patients' survey after RFA treatment. Anal pain scale range: 0-10 (minimum pain=0, maximum pain=10)</description>
        <time_frame>within 4 weeks post RFA</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Radiofrequency Ablation</title>
            <description>circumferential radiofrequency ablation (RFA) to the anal canal&#xD;
Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Tolerability: Post -Ablation Anal Pain</title>
          <description>Median post-ablation anal pain from 10 patients' survey after RFA treatment. Anal pain scale range: 0-10 (minimum pain=0, maximum pain=10)</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="2" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life Assessment: Subject Score for Worry About Anal Canal Condition</title>
        <description>Median from subject scores for worry about anal canal condition at 0-2 weeks prior to RFA treatment and after 9-12 months post RFA. Median scale range: 0-10 (minimum concern=0, maximum concern=10)</description>
        <time_frame>0-2 weeks Prior RFA and after 9-12 months post RFA</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Radiofrequency Ablation</title>
            <description>circumferential radiofrequency ablation (RFA) to the anal canal&#xD;
Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2.</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life Assessment: Subject Score for Worry About Anal Canal Condition</title>
          <description>Median from subject scores for worry about anal canal condition at 0-2 weeks prior to RFA treatment and after 9-12 months post RFA. Median scale range: 0-10 (minimum concern=0, maximum concern=10)</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0-2 weeks Prior RFA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" lower_limit="0" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 to 12 months post RFA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="0" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Radiofrequency Ablation</title>
          <description>circumferential radiofrequency ablation (RFA) to the anal canal&#xD;
Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Anal Stricture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>External thrombosed Hemorrhoids</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Stephen E. Goldstone, MD</name_or_title>
      <organization>Laser Surgery Care</organization>
      <phone>212-242-6500</phone>
      <email>segmd@prodigy.net</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/NCT02189161
org study id: B-253
nct id: NCT02189161
lead sponsor: 
has dmc: No
Assess the safety, feasibility, and patient tolerability of circumferential radiofrequency
      ablation (RFA) to the anal canal for patients with anal intraepithelial neoplasia (AIN).
      Patients will have AIN with high grade squamous intraepithelial lesions (HSIL) and the RFA
      will be applied using the Barrx™ Ablation System.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Related Adverse Events
time frame: Within 12 months post RFA
description: Adverse event : Device relationship - Definite, Probable, Possible
measure: Subject Tolerability: Post -Ablation Anal Pain
time frame: within 4 weeks post RFA
description: Median post-ablation anal pain from 10 patients' survey after RFA treatment. Anal pain scale range: 0-10 (minimum pain=0, maximum pain=10)
measure: Quality of Life Assessment: Subject Score for Worry About Anal Canal Condition
time frame: 0-2 weeks Prior RFA and after 9-12 months post RFA
description: Median from subject scores for worry about anal canal condition at 0-2 weeks prior to RFA treatment and after 9-12 months post RFA. Median scale range: 0-10 (minimum concern=0, maximum concern=10)
arm group label: Radiofrequency Ablation
arm group type: Experimental
description: circumferential radiofrequency ablation (RFA) to the anal canal
intervention type: Device
intervention name: Radiofrequency Ablation (Barrx™)
description: Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2.
arm group label: Radiofrequency Ablation
other name: Barrx™ Ablation System
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Carcinoma in Situ
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 