Clinical trial NCT01970787: A Trial of Radiofrequency Ablation for Anal Intraepithelial Neoplasia Using the HALO Ablation System
Official title: A Trial of Radiofrequency Ablation for Anal Intraepithelial Neoplasia Using the HALO Ablation System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV-negative Subjects With Intra-anal Intraepithelial Neoplasia Containing High-Grade Squamous Intraepithelial Lesions
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2013-10-28
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

  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

Primary outcomes:
measure: Clearance of Anal HSIL (High Grade Squamous Intraepithelial Lesion (HSIL)
timeFrame: 12 months
Secondary outcomes:
measure: Feasibility and Ease of Technique
timeFrame: 12 months
measure: Tolerability
timeFrame: 12 months
measure: Adverse Events
timeFrame: 12 months
measure: Progression of HSIL to Cancer
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Laser Surgery Center
state: New York
Study officials:
References: