NCT01970787

A Trial of Radiofrequency Ablation for Anal Intraepithelial Neoplasia Using the HALO Ablation System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Single-center prospective pilot trial involving up to 22 subjects. This study will assess the feasibility, safety, and efficacy of radiofrequency ablation (RFA) to the anal canal using the FDA cleared HALO Ablation System to eradicate anal HSIL lesions in HIV-negative subjects with intra-anal intraepithelial neoplasia (AIN). The study intervention will demonstrate that a reasonable proportion of subjects will be histologically cleared of their anal HSIL within the ETZ in a tolerable and relatively safe manner

Conditions

• HIV-negative Subjects With Intra-anal Intraepithelial Neoplasia Containing High-Grade Squamous Intraepithelial Lesions

Interventions

Type	Name	Description
DEVICE	Radiofrequency Ablation (RFA) using the HALO Ablation System

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2013-10-28
• Last updated: 2017-02-06
• Results posted: 2016-07-14

Locations

1 site across 1 country: United States