A Safety & Efficacy Trial of Circumferential Anal Canal Radiofrequency

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Ain III
Anal Cancer
Anus Neoplasms
Carcinoma in Situ
Carcinoma, Squamous Cell
HPV-Related Squamous Cell Carcinoma
HSIL, High Grade Squamous Intraepithelial Lesions
Human Papilloma Virus
Human Papillomavirus Infection
Papilloma
Papillomavirus Infections
Squamous Intraepithelial Lesions of the Cervix

Clinical Trial Details

NCT number	NCT03302858
Study type	Interventional
Source	Laser Surgery Care
Contact	Murad M Khan, BA
Phone	212-242-6500
Email	murad.khan@icahn.mssm.edu
Status	Recruiting
Phase	Phase 2
Start date	October 2017
Completion date	October 2020

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms