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

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

Study Overview

• Status: Completed
• Conditions: HIV-negative Subjects With Intra-anal Intraepithelial Neoplasia Containing High-Grade Squamous Intraepithelial Lesions
• Intervention / Treatment: Device: Radiofrequency Ablation (RFA) using the HALO Ablation System

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10011
      • Laser Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RFA; Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions	Device: Radiofrequency Ablation (RFA) using the HALO Ablation System; Other Names: Barrx Ablation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clearance of Anal HSIL (High Grade Squamous Intraepithelial Lesion (HSIL)	Participants with histologic clearance of anal HSIL within the ETZ (eligible treatment zone) at 12 months from first RFA treatment	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. Data not collected and could not be analyzed	12 months
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
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
Progression of HSIL to Cancer	Histologic progression of HSIL to cancer as measured in biopsies read at the central pathology lab. Data not collected and could not be analyzed.	12 months

Collaborators and Investigators

• Sponsor: Medtronic - MITG

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: October 22, 2013
• First Submitted That Met QC Criteria: October 25, 2013
• First Posted (Estimate): October 28, 2013

Study Record Updates

• Last Update Posted (Estimate): February 6, 2017
• Last Update Submitted That Met QC Criteria: December 12, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms; Carcinoma in Situ
• Other Study ID Numbers: B-250