Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Covidien, GI Solutions Identifier:
First received: October 22, 2013
Last updated: February 2, 2015
Last verified: February 2015

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

Condition Intervention
HIV-negative Subjects With Intra-anal Intraepithelial Neoplasia Containing High-grade Squamous Intraepithelial Lesions.
Device: Radiofrequency Ablation (RFA) using the HALO Ablation System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Trial of Radiofrequency Ablation for Anal Intraepithelial Neopplasia Using the HALO Ablation System

Resource links provided by NLM:

Further study details as provided by Covidien, GI Solutions:

Primary Outcome Measures:
  • Clearance of HSIL [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Histologic clearance of HSIL within the ETZ on a subject basis at 12 months from first RFA

Secondary Outcome Measures:
  • Feasibility and ease of technique [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Tolerability [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    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.

  • Adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Any related adverse event occuring in patients enrolled in this study. Event type and relationship to the device or procedure will be measured.

  • Progression of HSIL to cancer [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Histologic progression of HSIL to cancer as measured in biopsies read at the central pathology lab.

Estimated Enrollment: 22
Study Start Date: March 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Barrx Ablation System


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01970787

United States, New York
Laser Surgery Center
New York, New York, United States, 10011
Sponsors and Collaborators
Covidien, GI Solutions
  More Information

No publications provided

Responsible Party: Covidien, GI Solutions Identifier: NCT01970787     History of Changes
Other Study ID Numbers: B-250
Study First Received: October 22, 2013
Last Updated: February 2, 2015
Health Authority: United States: Food and Drug Administration processed this record on March 03, 2015