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

• ClinicalTrials.gov Identifier: NCT02189161
• Recruitment Status: Completed
• First Posted: July 14, 2014
• Results First Posted: July 14, 2016
• Last Update Posted: July 14, 2016
• Sponsor: Medtronic - MITG
• Information provided by (Responsible Party): Medtronic - MITG

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Anal Intraepithelial Neoplasia (AIN); High-grade Squamous Intraepithelial Lesions (HSIL)	Device: Radiofrequency Ablation (Barrx™)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Safety and Tolerability Trial of Circumferential Anal Canal Radiofrequency Ablation For Anal Intraepithelial Neoplasia Using the Barrx™ Ablation System
• Study Start Date: July 2014
• Actual Primary Completion Date: August 2015
• Actual Study Completion Date: August 2015

Arms and Interventions

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 Name: Barrx™ Ablation System

Outcome Measures

Primary Outcome Measures :

1. Related Adverse Events [ Time Frame: Within 12 months post RFA ]
   Adverse event : Device relationship - Definite, Probable, Possible

Secondary Outcome Measures :

1. Subject Tolerability: Post -Ablation Anal Pain [ Time Frame: within 4 weeks post RFA ]
   Median post-ablation anal pain from 10 patients' survey after RFA treatment. Anal pain scale range: 0-10 (minimum pain=0, maximum pain=10)
2. Quality of Life Assessment: Subject Score for Worry About Anal Canal Condition [ Time Frame: 0-2 weeks Prior RFA and after 9-12 months post RFA ]
   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)

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, New York

Laser Surgery Care

New York, New York, United States, 10011

Sponsors and Collaborators

Medtronic - MITG

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Medtronic - MITG
• ClinicalTrials.gov Identifier: NCT02189161
• Other Study ID Numbers: B-253
• First Posted: July 14, 2014
• Results First Posted: July 14, 2016
• Last Update Posted: July 14, 2016
• Last Verified: June 2016

Keywords provided by Medtronic - MITG:

anal intraepithelial neoplasia; AIN; Radiofrequency Ablation; RFA

Additional relevant MeSH terms:

Neoplasms; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type