Neoplasms

All Conditions

Carcinoma

Carcinoma in Situ

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

circumferential radiofrequency ablation (RFA) to the anal canal

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.

Radiofrequency Ablation (Barrx™)

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.

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

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

Adverse event : Device relationship - Definite, Probable, Possible

Median post-ablation anal pain from 10 patients' survey after RFA treatment. Anal pain scale range: 0-10 (minimum pain=0, maximum pain=10)

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)

Medtronic - MITG

circumferential radiofrequency ablation (RFA) to the anal canal

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.

Radiofrequency Ablation

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

subjects who have biopsy-proven HSIL and are HIV-negative or HIV-positive.

Spots Global Cancer Trial Database for radiofrequency ablation (barrx™)