<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/NCT03302858</url>
  </required_header>
  <id_info>
    <org_study_id>01-2017</org_study_id>
    <nct_id>NCT03302858</nct_id>
  </id_info>
  <brief_title>A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for High-Grade Anal Intraepithelial Neoplasia Using the BARRX™ Anorectal Wand</brief_title>
  <official_title>A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for High-Grade Anal Intraepithelial Neoplasia Using the BARRX™ Anorectal Wand</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stephen E. Goldstone</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laser Surgery Care</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is to assess the safety and effectiveness of circumferential&#xD;
      radiofrequency ablation (RFA) to the anal canal using the BarrxTM Ablation System to destroy&#xD;
      anal high-grade squamous intraepithelial lesions (HSIL). The BarrxTM Ablation System used in&#xD;
      this study comprises an RFA generator (Barrx™ FLEX) and the BarrxTM Anorectal Wand. The&#xD;
      generator and wand are cleared by the Food and Drug Administration (FDA) for human use and&#xD;
      the wand is specifically cleared for treatment of anal intraepithelial neoplasia (AIN). AIN&#xD;
      is a precancerous condition. HSIL is an advanced form of AIN. The presence of HSIL has&#xD;
      traditionally warranted treatment. RFA has been shown in many studies to effectively and&#xD;
      safely destroy precancerous cells in a condition called Barrett's esophagus, which is a&#xD;
      precancerous condition of the esophagus (the swallowing tube). Recent studies have shown that&#xD;
      RFA may offer the same benefits for those with HSIL in the anal canal. In particular,&#xD;
      ablation of the entire circumference of the canal seems to reduce recurrence of HSIL in other&#xD;
      locations of the anal canal.&#xD;
&#xD;
      This study will last between 12 to 15 months. Subjects will be required to undergo 5 to 8&#xD;
      study visits as outlined below that are carried out by the study doctors or the physician&#xD;
      assistant. Most visits will last approximately one hour. Some may be shorter and some may be&#xD;
      longer. Up to seventy (70) volunteers will participate in this study at several locations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">October 2017</start_date>
  <completion_date type="Anticipated">October 2020</completion_date>
  <primary_completion_date type="Anticipated">October 2019</primary_completion_date>
  <phase>Phase 2</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>Percent of patients who have histologically cleared high-grade squamous intraepithelial lesions (HSIL) at the SCJ at 12 months as measured by HRA</measure>
    <time_frame>12 months</time_frame>
    <description>Histologic clearance of all HSIL within the ETZ on a patient and lesion basis at 12 months from first RFA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Persistence of treated HSIL index lesions</measure>
    <time_frame>3 months post RFA</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of circumferential ablation of anal canal HSIL using the Barrx™ Anorectal Wand as defined by number of patients with adverse events (including prolonged pain, bleeding, anal strictures, etc).</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of patients who have histologically cleared low-grade squamous intraepithelial lesions (LSIL) at the SCJ at 12 months as measured by HRA</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">70</enrollment>
  <condition>HSIL, High Grade Squamous Intraepithelial Lesions</condition>
  <condition>Anal Cancer</condition>
  <condition>HPV-Related Squamous Cell Carcinoma</condition>
  <condition>Human Papilloma Virus</condition>
  <condition>Human Papillomavirus Infection</condition>
  <condition>Ain III</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BARRX™ Anorectal Wand</intervention_name>
    <description>The radiofrequency ablation (RFA) or Barrx™ Ablation System used in this protocol comprises an RFA generator (Barrx™ FLEX) and the Barrx™ Anorectal Wand. The generator and wand are cleared by the FDA for human use and the wand is specifically cleared for treatment of anal neoplasia. The present FDA indication for use statement is: &quot;The Barrx™ catheters are indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including, but not limited to, the esophagus. Indications include esophageal ulcers, Mallory-Weiss tears, arteriovenous malformations, angiomata, Barrett's esophagus, Dieulafoy lesions, angiodysplasia, gastric antral vascular ectasia, and radiation proctitis.&quot;</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion 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, non-&#xD;
             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;
        Exclusion Criteria:&#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;
          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 3 months prior to the 0&#xD;
             month RFA visit (other than cauterization or excision of condylomata)&#xD;
&#xD;
         10. History of topical therapy (e.g. Imiquimod, 5-FU, Trichloroacetic acid) within the&#xD;
&#xD;
             ETZ within 3 months prior to the 0 month RFA visit&#xD;
&#xD;
         11. Hemorrhoids &gt; grade III&#xD;
&#xD;
         12. Fecal incontinence&#xD;
&#xD;
         13. Concurrent disease requiring systemic immunosuppression therapy&#xD;
&#xD;
         14. Concurrent malignancy requiring systemic therapy&#xD;
&#xD;
         15. Life expectancy &lt; 2 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Murad M Khan, BA</last_name>
    <phone>212-242-6500</phone>
    <email>murad.khan@icahn.mssm.edu</email>
  </overall_contact>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephen E Goldstone, MD</last_name>
      <phone>212-242-6500</phone>
      <email>goldstone.stephen@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Stephen E Goldstone, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>October 4, 2017</last_update_submitted>
  <last_update_submitted_qc>October 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Laser Surgery Care</investigator_affiliation>
    <investigator_full_name>Stephen E. Goldstone</investigator_full_name>
    <investigator_title>Surgeon</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Papillomavirus Infections</mesh_term>
    <mesh_term>Papilloma</mesh_term>
    <mesh_term>Anus Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 31, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT03302858/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03302858
org study id: 01-2017
nct id: NCT03302858
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this research is to assess the safety and effectiveness of circumferential
      radiofrequency ablation (RFA) to the anal canal using the BarrxTM Ablation System to destroy
      anal high-grade squamous intraepithelial lesions (HSIL). The BarrxTM Ablation System used in
      this study comprises an RFA generator (Barrx™ FLEX) and the BarrxTM Anorectal Wand. The
      generator and wand are cleared by the Food and Drug Administration (FDA) for human use and
      the wand is specifically cleared for treatment of anal intraepithelial neoplasia (AIN). AIN
      is a precancerous condition. HSIL is an advanced form of AIN. The presence of HSIL has
      traditionally warranted treatment. RFA has been shown in many studies to effectively and
      safely destroy precancerous cells in a condition called Barrett's esophagus, which is a
      precancerous condition of the esophagus (the swallowing tube). Recent studies have shown that
      RFA may offer the same benefits for those with HSIL in the anal canal. In particular,
      ablation of the entire circumference of the canal seems to reduce recurrence of HSIL in other
      locations of the anal canal.

      This study will last between 12 to 15 months. Subjects will be required to undergo 5 to 8
      study visits as outlined below that are carried out by the study doctors or the physician
      assistant. Most visits will last approximately one hour. Some may be shorter and some may be
      longer. Up to seventy (70) volunteers will participate in this study at several locations.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percent of patients who have histologically cleared high-grade squamous intraepithelial lesions (HSIL) at the SCJ at 12 months as measured by HRA
time frame: 12 months
description: Histologic clearance of all HSIL within the ETZ on a patient and lesion basis at 12 months from first RFA
measure: Persistence of treated HSIL index lesions
time frame: 3 months post RFA
measure: Safety of circumferential ablation of anal canal HSIL using the Barrx™ Anorectal Wand as defined by number of patients with adverse events (including prolonged pain, bleeding, anal strictures, etc).
time frame: 12 months
measure: Percent of patients who have histologically cleared low-grade squamous intraepithelial lesions (LSIL) at the SCJ at 12 months as measured by HRA
time frame: 12 months
intervention type: Device
intervention name: BARRX™ Anorectal Wand
description: The radiofrequency ablation (RFA) or Barrx™ Ablation System used in this protocol comprises an RFA generator (Barrx™ FLEX) and the Barrx™ Anorectal Wand. The generator and wand are cleared by the FDA for human use and the wand is specifically cleared for treatment of anal neoplasia. The present FDA indication for use statement is: "The Barrx™ catheters are indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including, but not limited to, the esophagus. Indications include esophageal ulcers, Mallory-Weiss tears, arteriovenous malformations, angiomata, Barrett's esophagus, Dieulafoy lesions, angiodysplasia, gastric antral vascular ectasia, and radiation proctitis."
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Murad M Khan, BA
phone: 212-242-6500
email: murad.khan@icahn.mssm.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Laser Surgery Care
investigator full name: Stephen E. Goldstone
investigator title: Surgeon
mesh term: Papillomavirus Infections
mesh term: Papilloma
mesh term: Anus Neoplasms
sharing ipd: No
provided document: 