Anal Cancer Clinical Trial
Official title:
A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for High-Grade Anal Intraepithelial Neoplasia Using the BARRX™ Anorectal Wand
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.
n/a
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