A Trial of Radiofrequency Ablation for Anal Intraepithelial Neoplasia Using the HALO Ablation System (AIN)

Medtronic

Status: Completed

Conditions: HIV-negative Subjects With Intra-anal Intraepithelial Neoplasia Containing High-Grade Squamous Intraepithelial Lesions

Treatments: Device: Radiofrequency Ablation (RFA) using the HALO Ablation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01970787

B-250

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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
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  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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

RFA

Experimental group

Description:

Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions

Treatment:

Device: Radiofrequency Ablation (RFA) using the HALO Ablation System