N/A
N=10
A Safety and Tolerability of Circumferential Anal Canal Radiofrequency Ablation For Anal Intraepithelial Neoplasia
Anal Intraepithelial Neoplasia (AIN) · High-grade Squamous Intraepithelial Lesions (HSIL)
Bottom Line
View on ClinicalTrials.gov: NCT02189161 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Related Adverse Events — 1; 1 number of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Radiofrequency Ablation (Barrx™) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Related Adverse Events |
1; 1 | — |
| SECONDARY Subject Tolerability: Post -Ablation Anal Pain |
5 | — |
| SECONDARY Quality of Life Assessment: Subject Score for Worry About Anal Canal Condition |
4.5; 0.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
Candidates for this study must meet all of the following 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
- Located entirely within the eligible treatment zone AND
- Contiguous with the squamocolumnar junction
- Eligible treatment zone (ETZ) is defined as
- 3 cm above the dentate line to the anocutaneous line AND
- Full anorectal circumference
- 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
- HIV positive on antiretroviral therapy for at least 3 months with laboratory blood work within 12 weeks prior to the 0 month visit demonstrating viral load 750/mm3
- Platelet count ≥ 75,000/mm3
- Hemoglobin ≥ 9.0 g/dl
- INR and PTT normal
Exclusion Criteria
Candidates will be ineligible for enrollment in the study if any of the following conditions apply:
- 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
- Note: Condylomas in the eligible treatment zone grade III
- Fecal incontinence
- Concurrent disease requiring systemic immunosuppression therapy
- Concurrent malignancy requiring systemic therapy
- Life expectancy < 2 years
- Subject is on a platelet inhibiting agent (i.e. Aspirin, Clopidogrel, NSAIDS) and/or anti-thrombotic agent (Heparin, Warfarin) and unable to discontinue 7 days before and after treatment for 14 days total.
- Exception: Aspirin 81 mg PO daily does not need to be discontinued
Data sourced from ClinicalTrials.gov (NCT02189161). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.