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

A Safety and Tolerability Trial of Circumferential Anal Canal Radiofrequency Ablation For Anal Intraepithelial Neoplasia Using the Barrx™ Ablation System

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.

Study Overview

• Status: Completed
• Conditions: Anal Intraepithelial Neoplasia (AIN); High-grade Squamous Intraepithelial Lesions (HSIL)
• Intervention / Treatment: Device: Radiofrequency Ablation (Barrx™)

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

Candidates for this study must meet all of the following criteria:

1. Age 18-75 years

2. 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

3. Eligible treatment zone (ETZ) is defined as

   • 3 cm above the dentate line to the anocutaneous line AND
   • Full anorectal circumference
4. 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).

5. 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
   • INR and PTT normal

Exclusion Criteria

Candidates will be ineligible for enrollment in the study if any of the following conditions apply:

1. Any biopsy-proven HSIL partially outside of the ETZ (for example, an HSIL lesion with extension to the perianal skin)

2. 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)

3. Any anal or rectal pathology requiring treatment including ulcer, fistula, fissure, or proctitis
4. Any anal stricture or stenosis in patient history or upon examination.
5. Symptomatic scarring in anal canal (i.e. not pliable, hyperkeratosis)
6. History of or present anal or rectal cancer
7. History of pelvic radiation therapy
8. History of HPV vaccination or plans to initiate HPV vaccination during the trial
9. 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))
10. Prior ablation or resection therapy consisting of ≥ 75% circumference within the ETZ of anal canal.
11. History of topical therapy (e.g. Imiquimod, 5-FU, Trichloroacetic acid) within the ETZ within 3 months prior to the 0 month RFA visit
12. Hemorrhoids > grade III
13. Fecal incontinence
14. Concurrent disease requiring systemic immunosuppression therapy
15. Concurrent malignancy requiring systemic therapy
16. Life expectancy < 2 years

17. Subject is on a platelet inhibiting agent (i.e. Aspirin, Clopidogrel, NSAIDS) and/or anti-thrombotic agent (Heparin, Warfarin) and unable to discontinue 7 days before and after treatment for 14 days total.

    • Exception: Aspirin 81 mg PO daily does not need to be discontinued

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: Radiofrequency Ablation; circumferential radiofrequency ablation (RFA) to the anal canal

Device: Radiofrequency Ablation (Barrx™); 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.; Other Names: Barrx™ Ablation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Related Adverse Events	Adverse event : Device relationship - Definite, Probable, Possible	Within 12 months post RFA

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Tolerability: Post -Ablation Anal Pain	Median post-ablation anal pain from 10 patients' survey after RFA treatment. Anal pain scale range: 0-10 (minimum pain=0, maximum pain=10)	within 4 weeks post RFA
Quality of Life Assessment: Subject Score for Worry About Anal Canal Condition	Median from subject scores for worry about anal canal condition at 0-2 weeks prior to RFA treatment and after 9-12 months post RFA. Median scale range: 0-10 (minimum concern=0, maximum concern=10)	0-2 weeks Prior RFA and after 9-12 months post RFA

Collaborators and Investigators

• Sponsor: Medtronic - MITG

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: July 10, 2014
• First Submitted That Met QC Criteria: July 11, 2014
• First Posted (Estimate): July 14, 2014

Study Record Updates

• Last Update Posted (Estimate): July 14, 2016
• Last Update Submitted That Met QC Criteria: June 3, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Radiofrequency Ablation; RFA; AIN; anal intraepithelial neoplasia
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms; Carcinoma in Situ
• Other Study ID Numbers: B-253