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

NCT03302858 | Unknown Phase 2 FDA Device

• 1 other identifier: 01-2017
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

HSIL, High Grade Squamous Intraepithelial Lesions; Anal Cancer; HPV-Related Squamous Cell Carcinoma; Human Papilloma Virus; Human Papillomavirus Infection; Ain III

Outcome Measures

Primary Outcomes (1)

• Percent of patients who have histologically cleared high-grade squamous intraepithelial lesions (HSIL) at the SCJ at 12 months as measured by HRA

  Histologic clearance of all HSIL within the ETZ on a patient and lesion basis at 12 months from first RFA

  12 months

Secondary Outcomes (3)

• Persistence of treated HSIL index lesions

  3 months post RFA

• 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).

  12 months

• Percent of patients who have histologically cleared low-grade squamous intraepithelial lesions (LSIL) at the SCJ at 12 months as measured by HRA

  12 months

Interventions

BARRX™ Anorectal Wand DEVICE

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."

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years
• 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
• Eligible treatment zone (ETZ) is defined as
• cm above the dentate line to the anocutaneous line AND
• Full anorectal circumference
• 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).
• 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

You may not qualify if:

• Any biopsy-proven HSIL partially outside of the ETZ (for example, an HSIL lesion with extension to the perianal skin)
• Any condylomas in the eligible treatment zone \> 1/2 cm diameter
• Any anal or rectal pathology requiring treatment including ulcer, fistula, fissure, or proctitis
• Any anal stricture or stenosis in patient history or upon examination.
• Symptomatic scarring in anal canal (i.e. not pliable, hyperkeratosis)
• History of or present anal or rectal cancer
• History of pelvic radiation therapy
• History of HPV vaccination or plans to initiate HPV vaccination during the trial
• 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)
• History of topical therapy (e.g. Imiquimod, 5-FU, Trichloroacetic acid) within the
• ETZ within 3 months prior to the 0 month RFA visit
• Hemorrhoids \> grade III
• Fecal incontinence
• Concurrent disease requiring systemic immunosuppression therapy
• Concurrent malignancy requiring systemic therapy

Sponsors & Collaborators

• Stephen E. Goldstone: lead

Study Sites (1)

Laser Surgery Care

New York, New York, 10011, United States

RECRUITING

MeSH Terms

Conditions

Squamous Intraepithelial Lesions; Anus Neoplasms; Papillomavirus Infections

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms; Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes

Central Study Contacts

Murad M Khan, BA

CONTACT

212-242-6500; murad.khan@icahn.mssm.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Surgeon

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: October 5, 2017
• Study Start: October 1, 2017
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2020
• Last Updated: October 5, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)