HIV-negative Subjects With Intra-anal Intraepithelial Neoplasia Containing High-grade Squamous Intraepithelial Lesions. Clinical Trial
— AINOfficial title:
A Trial of Radiofrequency Ablation for Anal Intraepithelial Neopplasia Using the HALO Ablation System
| Verified date | July 2015 |
| Source | Medtronic - MITG |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 22 |
| Est. completion date | June 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 1. Located entirely within in the eligible treatment zone 2. Contiguous with the squamocolumnar junction Eligible treatment zone (ETZ) is defined as 1. 3 cm above the dentate line to the anocutaneous line 2. 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: 1. Any biopsy-proven HSIL entirely outside of the ETZ 2. Any biopsy-proven HSIL partially within the ETZ (for example, an HSIL lesion with extension to the perianal skin) 3. Any condylomas in the eligible treatment zone > 1/2 cm diameter • Note: Condylomas in the eligible treatment zone < 1/2 cm in diameter must be excised or cauterized (not treated topically or with IRC) before or during Visit 1 (0 month RFA visit) 4. Any anal or rectal pathology requiring treatment including ulcer, fistula, fissure, stenosis or proctitis 5. History of or present anal or rectal cancer 6. History of pelvic radiation therapy 7. History of HPV vaccination or plans to initiate HPV vaccination during the trial 8. History of ablation or resection therapy within the ETZ other than cauterization or excision of condyloma(s) 9. History of topical therapy (Imiquimod, 5-FU) within 6 months prior to the 0 month RFA visit within the ETZ 10. Hemorrhoids > grade II 11. Fecal incontinence (that the investigator feels may impair healing) 12. Concurrent disease requiring systemic immunosuppression therapy 13. Concurrent malignancy requiring systemic therapy 14. Life expectancy < 2 years |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Laser Surgery Center | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Medtronic - MITG |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clearance of HSIL | Histologic clearance of HSIL within the ETZ on a subject basis at 12 months from first RFA | 12 months | No |
| Secondary | Feasibility and ease of technique | Technical feasibility of applying RFA to the anal canal. Physician's assessment of ablation as optimal (complete ablation) versus sub-optimal (incomplete ablation)in the affected area in the anal canal. | 12 months | No |
| Secondary | Tolerability | Subject tolerability of the RFA procedure as measured by severity. Mild: Awareness of signs and symptoms, but easily tolerated; are of a minor irritant type; causing no loss of time from normal activities; symptoms would not require medication or a medical intervention; asymptomatic lab findings; marginal clinical relevance; signs and symptoms are transient. Moderate: Discomfort severe enough to cause interference with usual activities; minimal intervention. Severe: Incapacitating with inability to do work or usual activities; signs and symptoms may be of systemic nature or require medical evaluation or treatment. |
12 months | Yes |
| Secondary | Adverse events | Any related adverse event occuring in patients enrolled in this study. Event type and relationship to the device or procedure will be measured. | 12 months | Yes |
| Secondary | Progression of HSIL to cancer | Histologic progression of HSIL to cancer as measured in biopsies read at the central pathology lab. | 12 months | No |