A Safety and Tolerability of Circumferential Anal Canal Radiofrequency Ablation For Anal Intraepithelial Neoplasia
- Conditions
- High-grade Squamous Intraepithelial Lesions (HSIL)Anal Intraepithelial Neoplasia (AIN)
- Interventions
- Device: Radiofrequency Ablation (Barrx™)
- Registration Number
- NCT02189161
- Lead Sponsor
- Medtronic - MITG
- Brief Summary
Assess the safety, feasibility, and patient tolerability of circumferential radiofrequency ablation (RFA) to the anal canal for patients with anal intraepithelial neoplasia (AIN). Patients will have AIN with high grade squamous intraepithelial lesions (HSIL) and the RFA will be applied using the Barrx™ Ablation System.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Radiofrequency Ablation Radiofrequency Ablation (Barrx™) circumferential radiofrequency ablation (RFA) to the anal canal
- Primary Outcome Measures
Name Time Method Related Adverse Events Within 12 months post RFA Adverse event : Device relationship - Definite, Probable, Possible
- Secondary Outcome Measures
Name Time Method Quality of Life Assessment: Subject Score for Worry About Anal Canal Condition 0-2 weeks Prior RFA and after 9-12 months post RFA Median from subject scores for worry about anal canal condition at 0-2 weeks prior to RFA treatment and after 9-12 months post RFA. Median scale range: 0-10 (minimum concern=0, maximum concern=10)
Subject Tolerability: Post -Ablation Anal Pain within 4 weeks post RFA Median post-ablation anal pain from 10 patients' survey after RFA treatment. Anal pain scale range: 0-10 (minimum pain=0, maximum pain=10)
Trial Locations
- Locations (1)
Laser Surgery Care
🇺🇸New York, New York, United States