A Safety and Tolerability of Circumferential Anal Canal Radiofrequency Ablation For Anal Intraepi… (NCT02189161) | Clinical Trial Compass
CompletedNot Applicable
A Safety and Tolerability of Circumferential Anal Canal Radiofrequency Ablation For Anal Intraepithelial Neoplasia
United States10 participantsStarted 2014-07
Plain-language 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 Barrxâ„¢ Ablation System.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age 18-75 years
✓. HRA 2 to 8 weeks prior to the 0 month RFA visit yielding one or more flat, non-condylomatous biopsy-proven HSILs that are
✓. Eligible treatment zone (ETZ) is defined as
✓. If female of child-bearing age, negative pregnancy test within 8 weeks of the 0 month RFA visit and declared intent to remain on birth control throughout the trial, or declaration of infertility defined as subject report of status as post-menopausal or surgically sterile (status post hysterectomy or tubal ligation).
✓. If HIV positive
Exclusion criteria
✕. Any biopsy-proven HSIL partially outside of the ETZ (for example, an HSIL lesion with extension to the perianal skin)
✕. Any condylomas in the eligible treatment zone \> 1/2 cm diameter
✕. Any anal or rectal pathology requiring treatment including ulcer, fistula, fissure, or proctitis
✕. Any anal stricture or stenosis in patient history or upon examination.
✕. Symptomatic scarring in anal canal (i.e. not pliable, hyperkeratosis)