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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Medtronic - MITG

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

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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

Resource links provided by the National Library of Medicine


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




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)



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189161


Locations
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United States, New York
Laser Surgery Care
New York, New York, United States, 10011
Sponsors and Collaborators
Medtronic - MITG
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT02189161    
Other Study ID Numbers: B-253
First Posted: July 14, 2014    Key Record Dates
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:
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Neoplasms
Carcinoma in Situ
Squamous Intraepithelial Lesions of the Cervix
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Uterine Cervical Dysplasia
Precancerous Conditions
Uterine Cervical Diseases
Uterine Diseases