CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Radiofrequency Ablation (Barrx™)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02189161
NCT02189161N/ACompleted
CompareCT.gov

A Safety and Tolerability Trial of Circumferential Anal Canal Radiofrequency Ablation For Anal Intraepithelial Neoplasia Using the Barrx™ Ablation System

Medtronic - MITG·interventional·Posted Jul 14, 2014·Updated Jul 14, 2016

In Brief

A clinical study evaluating Radiofrequency Ablation (Barrx™) for Anal Intraepithelial Neoplasia (AIN) and High-grade Squamous Intraepithelial Lesions (HSIL). Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnal Intraepithelial Neoplasia (AIN), High-grade Squamous Intraepithelial Lesions (HSIL)
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 14, 2014
Enrollment StartJul 1, 2014
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.0 years ago

Interventions

Radiofrequency Ablation (Barrx™)device

Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2.