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 Barrx™ Ablation System.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial specifically tested radiofrequency ablation applied all the way around the anal canal for high-grade AIN — how does that 'circumferential' approach differ from what's typically done, and why might that matter for someone in my situation?
2Since this was a safety and tolerability study rather than a phase that measures whether the treatment actually works long-term, what do the results tell us about the risks and side effects, and is there enough follow-up data yet to know whether it's effective?
3The trial has completed — has the safety data from this study been published, and does it change how you'd recommend treating my high-grade AIN compared to standard options like infrared coagulation or surgical removal?
4Given that the main thing this study was measuring was adverse events, what were the most common or serious side effects reported, and how would those affect my day-to-day life during and after treatment?
5Before considering an approach like this one, would you recommend trying a more established treatment first, or is circumferential radiofrequency ablation something worth pursuing now based on the completed trial results?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.