A Trial of Radiofrequency Ablation for Anal Intraepithelial Neoplasia Using the HALO Ablation System (AIN)
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|ClinicalTrials.gov Identifier: NCT01970787|
Recruitment Status : Completed
First Posted : October 28, 2013
Results First Posted : July 14, 2016
Last Update Posted : February 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV-negative Subjects With Intra-anal Intraepithelial Neoplasia Containing High-Grade Squamous Intraepithelial Lesions||Device: Radiofrequency Ablation (RFA) using the HALO Ablation System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Trial of Radiofrequency Ablation for Anal Intraepithelial Neoplasia Using the HALO Ablation System|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01970787
|United States, New York|
|Laser Surgery Center|
|New York, New York, United States, 10011|