A Safety and Tolerability of Circumferential Anal Canal Radiofrequency Ablation For Anal Intraepithelial Neoplasia

Not Applicable

Completed

• Conditions: High-grade Squamous Intraepithelial Lesions (HSIL); Anal Intraepithelial Neoplasia (AIN)

• 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

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-10
• Study First Submitted QC: 2014-07-11
• Study First Posted: 2014-07-14
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Results First Submitted: 2016-04-26
• Status Verified: 2016-06
• Results First Submitted QC: 2016-06-03
• Last Update Submitted: 2016-06-03
• Results First Posted: 2016-07-14
• Last Update Posted: 2016-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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