A Safety and Tolerability of Circumferential Anal Canal Radiofrequency Ablation For Anal Intraepithelial Neoplasia

NCT02189161 | Completed Results

• 1 other identifier: B-253
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Assess the safety, feasibility, and patient tolerability of circumferential radiofrequency ablation (RFA) to the anal canal for patients with anal intraepithelial neoplasia (AIN). Patients will have AIN with high grade squamous intraepithelial lesions (HSIL) and the RFA will be applied using the Barrx™ Ablation System.

Conditions

Anal Intraepithelial Neoplasia (AIN); High-grade Squamous Intraepithelial Lesions (HSIL)

Keywords

anal intraepithelial neoplasia; AIN; Radiofrequency Ablation; RFA

Outcome Measures

Primary Outcomes (1)

• Related Adverse Events

  Adverse event : Device relationship - Definite, Probable, Possible

  Within 12 months post RFA

Secondary Outcomes (2)

• Subject Tolerability: Post -Ablation Anal Pain

  within 4 weeks post RFA

• Quality of Life Assessment: Subject Score for Worry About Anal Canal Condition

  0-2 weeks Prior RFA and after 9-12 months post RFA

Study Arms (1)

Radiofrequency Ablation

EXPERIMENTAL

circumferential radiofrequency ablation (RFA) to the anal canal

Device: Radiofrequency Ablation (Barrx™)

Interventions

Radiofrequency Ablation (Barrx™) DEVICE

Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2.

Also known as: Barrx™ Ablation System

Radiofrequency Ablation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Candidates for this study must meet all of the following criteria:
• Age 18-75 years
• HRA 2 to 8 weeks prior to the 0 month RFA visit yielding one or more flat, non-condylomatous biopsy-proven HSILs that are
• Located entirely within the eligible treatment zone AND
• Contiguous with the squamocolumnar junction
• Eligible treatment zone (ETZ) is defined as
• cm above the dentate line to the anocutaneous line AND
• Full anorectal circumference
• 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).
• If HIV positive
• HIV positive on antiretroviral therapy for at least 3 months with laboratory blood work within 12 weeks prior to the 0 month visit demonstrating viral load \< 50
• CD4 count ≥ 250/mm3
• ANC \> 750/mm3
• Platelet count ≥ 75,000/mm3
• Hemoglobin ≥ 9.0 g/dl

You may not qualify if:

• Candidates will be ineligible for enrollment in the study if any of the following conditions apply:
• Any biopsy-proven HSIL partially outside of the ETZ (for example, an HSIL lesion with extension to the perianal skin)
• 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) before or during Visit 1 (0 month RFA visit)
• Any anal or rectal pathology requiring treatment including ulcer, fistula, fissure, or proctitis
• Any anal stricture or stenosis in patient history or upon examination.
• Symptomatic scarring in anal canal (i.e. not pliable, hyperkeratosis)
• History of or present anal or rectal cancer
• History of pelvic radiation therapy
• History of HPV vaccination or plans to initiate HPV vaccination during the trial
• History of ablation or resection therapy within the ETZ within 6 months prior to the 0 month RFA visit (other than cauterization or excision of condyloma(s))
• Prior ablation or resection therapy consisting of ≥ 75% circumference within the ETZ of anal canal.
• History of topical therapy (e.g. Imiquimod, 5-FU, Trichloroacetic acid) within the ETZ within 3 months prior to the 0 month RFA visit
• Hemorrhoids \> grade III
• Fecal incontinence

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Laser Surgery Care

New York, New York, 10011, United States

Location

Related Publications (1)

• Goldstone RN, Hasan SR, Goldstone SE. Brief Report: Radiofrequency Ablation Therapy for Anal Intraepithelial Neoplasia: Results From a Single-Center Prospective Pilot Study in HIV+ Participants. J Acquir Immune Defic Syndr. 2017 Dec 1;76(4):e93-e97. doi: 10.1097/QAI.0000000000001535.

  PMID: 28857936 DERIVED

MeSH Terms

Conditions

Squamous Intraepithelial Lesions

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Stephen E. Goldstone, MD
• Organization: Laser Surgery Care

segmd@prodigy.net

212-242-6500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 14, 2014
• Study Start: July 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: July 14, 2016
• Results First Posted: July 14, 2016

Record last verified: 2016-06

Locations

US (1)