N/A
N=22
A Trial of Radiofrequency Ablation for Anal Intraepithelial Neoplasia Using the HALO Ablation System
HIV-negative Subjects With Intra-anal Intraepithelial Neoplasia Containing High-Grade Squamous Intraepithelial Lesions
Bottom Line
View on ClinicalTrials.gov: NCT01970787 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Clearance of Anal HSIL (High Grade Squamous Intraepithelial Lesion (HSIL) — 19 participants w histological clearance
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Radiofrequency Ablation (RFA) using the HALO Ablation System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clearance of Anal HSIL (High Grade Squamous Intraepithelial Lesion (HSIL) |
19 | — |
| SECONDARY Feasibility and Ease of Technique |
— | — |
| SECONDARY Tolerability |
20; 12; 7; 1 | — |
| SECONDARY Adverse Events |
2 | — |
| SECONDARY Progression of HSIL to Cancer |
— | — |
Summary
This is a Single-center prospective pilot trial involving up to 22 subjects. This study will assess the feasibility, safety, and efficacy of radiofrequency ablation (RFA) to the anal canal using the FDA cleared HALO Ablation System to eradicate anal HSIL lesions in HIV-negative subjects with intra-anal intraepithelial neoplasia (AIN). The study intervention will demonstrate that a reasonable proportion of subjects will be histologically cleared of their anal HSIL within the ETZ in a tolerable and relatively safe manner
Eligibility Criteria
Inclusion Criteria
- Age 18-75 years
- HRA 2 to 12 weeks prior to the 0 month RFA visit yielding one or more flat, non-condylomatous biopsy-proven HSILs that are
- Located entirely within in the eligible treatment zone
- Contiguous with the squamocolumnar junction Eligible treatment zone (ETZ) is defined as
- 3 cm above the dentate line to the anocutaneous line
- Half of the anorectal circumference (meaning no more than two contiguous quadrants)
- 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).
- HIV negative, ELISA/Western blot test obtained within 12 weeks of the 0 month RFA visit
Exclusion Criteria
- Any biopsy-proven HSIL entirely outside of the ETZ
- Any biopsy-proven HSIL partially within 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 II
- Fecal incontinence (that the investigator feels may impair healing)
- Concurrent disease requiring systemic immunosuppression therapy
- Concurrent malignancy requiring systemic therapy
- Life expectancy < 2 years
Data sourced from ClinicalTrials.gov (NCT01970787). 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.