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

NACompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

July 31, 2014

Primary Completion Date

August 31, 2015

Study Completion Date

August 31, 2015

Conditions
Anal Intraepithelial Neoplasia (AIN)High-grade Squamous Intraepithelial Lesions (HSIL)
Interventions
DEVICE

Radiofrequency Ablation (Barrx™)

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.

Trial Locations (1)

10011

Laser Surgery Care, New York

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Medtronic - MITG

INDUSTRY