A Trial of Radiofrequency Ablation for Anal Intraepithelial Neoplasia Using the HALO Ablation System (AIN)
|HIV-negative Subjects With Intra-anal Intraepithelial Neoplasia Containing High-Grade Squamous Intraepithelial Lesions||Device: Radiofrequency Ablation (RFA) using the HALO Ablation System|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Trial of Radiofrequency Ablation for Anal Intraepithelial Neoplasia Using the HALO Ablation System|
- Clearance of Anal HSIL (High Grade Squamous Intraepithelial Lesion (HSIL) [ Time Frame: 12 months ]Participants with histologic clearance of anal HSIL within the ETZ (eligible treatment zone) at 12 months from first RFA treatment
- Feasibility and Ease of Technique [ Time Frame: 12 months ]
Technical feasibility of applying RFA to the anal canal. Physician's assessment of ablation as optimal (complete ablation) versus sub-optimal (incomplete ablation)in the affected area in the anal canal.
Data not collected and could not be analyzed
- Tolerability [ Time Frame: 12 months ]
Subject tolerability of the RFA procedure as measured by severity. Mild: Awareness of signs and symptoms, but easily tolerated; are of a minor irritant type; causing no loss of time from normal activities; symptoms would not require medication or a medical intervention; asymptomatic lab findings; marginal clinical relevance; signs and symptoms are transient.
Moderate: Discomfort severe enough to cause interference with usual activities; minimal intervention.
Severe: Incapacitating with inability to do work or usual activities; signs and symptoms may be of systemic nature or require medical evaluation or treatment.
- Adverse Events [ Time Frame: 12 months ]Any related adverse event occuring in patients enrolled in this study. Event type and relationship to the device or procedure will be measured.
- Progression of HSIL to Cancer [ Time Frame: 12 months ]Histologic progression of HSIL to cancer as measured in biopsies read at the central pathology lab. Data not collected and could not be analyzed.
|Study Start Date:||March 2013|
|Study Completion Date:||June 2015|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions
Device: Radiofrequency Ablation (RFA) using the HALO Ablation System
Other Name: Barrx Ablation System
Please refer to this study by its ClinicalTrials.gov identifier: NCT01970787
|United States, New York|
|Laser Surgery Center|
|New York, New York, United States, 10011|