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

Primary Purpose

HIV-negative Subjects With Intra-anal Intraepithelial Neoplasia Containing High-Grade Squamous Intraepithelial Lesions

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Radiofrequency Ablation (RFA) using the HALO Ablation System

About this trial

This is an interventional treatment trial for HIV-negative Subjects With Intra-anal Intraepithelial Neoplasia Containing High-Grade Squamous Intraepithelial Lesions

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Any biopsy-proven HSIL entirely outside of the ETZ
Any biopsy-proven HSIL partially within 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 or with IRC) before or during Visit 1 (0 month RFA visit)
Any anal or rectal pathology requiring treatment including ulcer, fistula, fissure, stenosis or proctitis
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 other than cauterization or excision of condyloma(s)
History of topical therapy (Imiquimod, 5-FU) within 6 months prior to the 0 month RFA visit within the ETZ
Hemorrhoids > grade II
Fecal incontinence (that the investigator feels may impair healing)
Concurrent disease requiring systemic immunosuppression therapy
Concurrent malignancy requiring systemic therapy
Life expectancy < 2 years

Sites / Locations

Laser Surgery Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RFA

Arm Description

Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions

Outcomes

Primary Outcome Measures

Clearance of Anal HSIL (High Grade Squamous Intraepithelial Lesion (HSIL)

Participants with histologic clearance of anal HSIL within the ETZ (eligible treatment zone) at 12 months from first RFA treatment

Secondary Outcome Measures

Feasibility and Ease of Technique

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. Data not collected and could not be analyzed

Tolerability

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

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

Histologic progression of HSIL to cancer as measured in biopsies read at the central pathology lab. Data not collected and could not be analyzed.

Full Information

NCT ID

NCT01970787

First Posted

October 22, 2013

Last Updated

December 12, 2016

Sponsor

Medtronic - MITG

1. Study Identification

Unique Protocol Identification Number

NCT01970787

Brief Title

A Trial of Radiofrequency Ablation for Anal Intraepithelial Neoplasia Using the HALO Ablation System

Acronym

AIN

Official Title

A Trial of Radiofrequency Ablation for Anal Intraepithelial Neoplasia Using the HALO Ablation System

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic - MITG

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV-negative Subjects With Intra-anal Intraepithelial Neoplasia Containing High-Grade Squamous Intraepithelial Lesions

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RFA

Arm Type

Experimental

Arm Description

Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions

Intervention Type

Device

Intervention Name(s)

Radiofrequency Ablation (RFA) using the HALO Ablation System

Other Intervention Name(s)

Barrx Ablation System

Primary Outcome Measure Information:

Title

Clearance of Anal HSIL (High Grade Squamous Intraepithelial Lesion (HSIL)

Description

Participants with histologic clearance of anal HSIL within the ETZ (eligible treatment zone) at 12 months from first RFA treatment

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Feasibility and Ease of Technique

Description

Time Frame

12 months

Title

Tolerability

Description

Time Frame

12 months

Title

Adverse Events

Description

Any related adverse event occuring in patients enrolled in this study. Event type and relationship to the device or procedure will be measured.

Time Frame

12 months

Title

Progression of HSIL to Cancer

Description

Histologic progression of HSIL to cancer as measured in biopsies read at the central pathology lab. Data not collected and could not be analyzed.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 Located entirely within in the eligible treatment zone Contiguous with the squamocolumnar junction Eligible treatment zone (ETZ) is defined as 3 cm above the dentate line to the anocutaneous line 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: Any biopsy-proven HSIL entirely outside of the ETZ Any biopsy-proven HSIL partially within 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 or with IRC) before or during Visit 1 (0 month RFA visit) Any anal or rectal pathology requiring treatment including ulcer, fistula, fissure, stenosis or proctitis 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 other than cauterization or excision of condyloma(s) History of topical therapy (Imiquimod, 5-FU) within 6 months prior to the 0 month RFA visit within the ETZ Hemorrhoids > grade II Fecal incontinence (that the investigator feels may impair healing) Concurrent disease requiring systemic immunosuppression therapy Concurrent malignancy requiring systemic therapy Life expectancy < 2 years

Facility Information:

Facility Name

Laser Surgery Center

City

New York

State/Province

New York

ZIP/Postal Code

10011

Country

United States

12. IPD Sharing Statement

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A Trial of Radiofrequency Ablation for Anal Intraepithelial Neoplasia Using the HALO Ablation System

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