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A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for High-Grade Anal Intraepithelial Neoplasia Using the BARRX™ Anorectal Wand

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ClinicalTrials.gov Identifier: NCT03302858
Recruitment Status : Recruiting
First Posted : October 5, 2017
Last Update Posted : October 5, 2017
Sponsor:
Information provided by (Responsible Party):
Stephen E. Goldstone, Laser Surgery Care

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
HSIL, High Grade Squamous Intraepithelial Lesions Anal Cancer HPV-Related Squamous Cell Carcinoma Human Papilloma Virus Human Papillomavirus Infection Ain III Device: BARRX™ Anorectal Wand Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for High-Grade Anal Intraepithelial Neoplasia Using the BARRX™ Anorectal Wand
Estimated Study Start Date : October 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: BARRX™ Anorectal Wand
    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."


Primary Outcome Measures :
  1. 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 ]
    Histologic clearance of all HSIL within the ETZ on a patient and lesion basis at 12 months from first RFA


Secondary Outcome Measures :
  1. Persistence of treated HSIL index lesions [ Time Frame: 3 months post RFA ]
  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 18-75 years
  2. HRA 2 to 8 weeks prior to the 0 month RFA visit yielding one or more flat, non- condylomatous biopsy-proven HSILs that are

    • Located entirely within the eligible treatment zone AND
    • Contiguous with the squamocolumnar junction
  3. Eligible treatment zone (ETZ) is defined as

    • 3 cm above the dentate line to the anocutaneous line AND
    • Full anorectal circumference
  4. If female of child-bearing age, negative pregnancy test within 8 weeks of the 0 month RFA visit and declared intent to remain on birth control throughout the trial, or declaration of infertility defined as subject report of status as post-menopausal or surgically sterile (status post hysterectomy or tubal ligation).
  5. If HIV positive

    • HIV positive on antiretroviral therapy for at least 3 months with laboratory blood work within 12 weeks prior to the 0 month visit demonstrating viral load < 50
    • CD4 count ≥ 250/mm3
    • ANC > 750/mm3
    • Platelet count ≥ 75,000/mm3
    • Hemoglobin ≥ 9.0 g/dl

Exclusion Criteria:

  1. Any biopsy-proven HSIL partially outside of the ETZ (for example, an HSIL lesion with extension to the perianal skin)
  2. Any condylomas in the eligible treatment zone > 1/2 cm diameter
  3. Any anal or rectal pathology requiring treatment including ulcer, fistula, fissure, or proctitis
  4. Any anal stricture or stenosis in patient history or upon examination.
  5. Symptomatic scarring in anal canal (i.e. not pliable, hyperkeratosis)
  6. History of or present anal or rectal cancer
  7. History of pelvic radiation therapy
  8. History of HPV vaccination or plans to initiate HPV vaccination during the trial
  9. History of ablation or resection therapy within the ETZ within 3 months prior to the 0 month RFA visit (other than cauterization or excision of condylomata)
  10. History of topical therapy (e.g. Imiquimod, 5-FU, Trichloroacetic acid) within the

    ETZ within 3 months prior to the 0 month RFA visit

  11. Hemorrhoids > grade III
  12. Fecal incontinence
  13. Concurrent disease requiring systemic immunosuppression therapy
  14. Concurrent malignancy requiring systemic therapy
  15. Life expectancy < 2 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03302858


Contacts
Contact: Murad M Khan, BA 212-242-6500 murad.khan@icahn.mssm.edu

Locations
United States, New York
Laser Surgery Care Recruiting
New York, New York, United States, 10011
Contact: Stephen E Goldstone, MD    212-242-6500    goldstone.stephen@gmail.com   
Principal Investigator: Stephen E Goldstone, MD         
Sponsors and Collaborators
Stephen E. Goldstone
  Study Documents (Full-Text)

Documents provided by Stephen E. Goldstone, Laser Surgery Care:

Responsible Party: Stephen E. Goldstone, Surgeon, Laser Surgery Care
ClinicalTrials.gov Identifier: NCT03302858     History of Changes
Other Study ID Numbers: 01-2017
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Papillomavirus Infections
Carcinoma, Squamous Cell
Carcinoma in Situ
Papilloma
Anus Neoplasms
Squamous Intraepithelial Lesions of the Cervix
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Uterine Cervical Dysplasia
Precancerous Conditions
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female