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A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for High-Grade Anal Intraepithelial Neoplasia Using the BARRX™ Anorectal Wand

Primary Purpose

HSIL, High Grade Squamous Intraepithelial Lesions, Anal Cancer, HPV-Related Squamous Cell Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

BARRX™ Anorectal Wand

About this trial

This is an interventional treatment trial for HSIL, High Grade Squamous Intraepithelial Lesions

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion 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
- 3 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

Exclusion Criteria:

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
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 3 months prior to the 0 month RFA visit (other than cauterization or excision of condylomata)
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
Concurrent disease requiring systemic immunosuppression therapy
Concurrent malignancy requiring systemic therapy
Life expectancy < 2 years

Sites / Locations

Laser Surgery CareRecruiting

Outcomes

Primary Outcome Measures

Percent of patients who have histologically cleared high-grade squamous intraepithelial lesions (HSIL) at the SCJ at 12 months as measured by HRA

Histologic clearance of all HSIL within the ETZ on a patient and lesion basis at 12 months from first RFA

Secondary Outcome Measures

Persistence of treated HSIL index lesions

Safety of circumferential ablation of anal canal HSIL using the Barrx™ Anorectal Wand as defined by number of patients with adverse events (including prolonged pain, bleeding, anal strictures, etc).

Percent of patients who have histologically cleared low-grade squamous intraepithelial lesions (LSIL) at the SCJ at 12 months as measured by HRA

Full Information

NCT ID

NCT03302858

First Posted

September 20, 2017

Last Updated

October 4, 2017

Sponsor

Stephen E. Goldstone

1. Study Identification

Unique Protocol Identification Number

NCT03302858

Brief Title

A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for High-Grade Anal Intraepithelial Neoplasia Using the BARRX™ Anorectal Wand

Official Title

A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for High-Grade Anal Intraepithelial Neoplasia Using the BARRX™ Anorectal Wand

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Unknown status

Study Start Date

October 2017 (Anticipated)

Primary Completion Date

October 2019 (Anticipated)

Study Completion Date

October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Stephen E. Goldstone

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this research is to assess the safety and effectiveness of circumferential radiofrequency ablation (RFA) to the anal canal using the BarrxTM Ablation System to destroy anal high-grade squamous intraepithelial lesions (HSIL). The BarrxTM Ablation System used in this study comprises an RFA generator (Barrx™ FLEX) and the BarrxTM Anorectal Wand. The generator and wand are cleared by the Food and Drug Administration (FDA) for human use and the wand is specifically cleared for treatment of anal intraepithelial neoplasia (AIN). AIN is a precancerous condition. HSIL is an advanced form of AIN. The presence of HSIL has traditionally warranted treatment. RFA has been shown in many studies to effectively and safely destroy precancerous cells in a condition called Barrett's esophagus, which is a precancerous condition of the esophagus (the swallowing tube). Recent studies have shown that RFA may offer the same benefits for those with HSIL in the anal canal. In particular, ablation of the entire circumference of the canal seems to reduce recurrence of HSIL in other locations of the anal canal. This study will last between 12 to 15 months. Subjects will be required to undergo 5 to 8 study visits as outlined below that are carried out by the study doctors or the physician assistant. Most visits will last approximately one hour. Some may be shorter and some may be longer. Up to seventy (70) volunteers will participate in this study at several locations.

6. Conditions and Keywords

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

HSIL, High Grade Squamous Intraepithelial Lesions, Anal Cancer, HPV-Related Squamous Cell Carcinoma, Human Papilloma Virus, Human Papillomavirus Infection, Ain III

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

BARRX™ Anorectal Wand

Intervention Description

The radiofrequency ablation (RFA) or Barrx™ Ablation System used in this protocol comprises an RFA generator (Barrx™ FLEX) and the Barrx™ Anorectal Wand. The generator and wand are cleared by the FDA for human use and the wand is specifically cleared for treatment of anal neoplasia. The present FDA indication for use statement is: "The Barrx™ catheters are indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including, but not limited to, the esophagus. Indications include esophageal ulcers, Mallory-Weiss tears, arteriovenous malformations, angiomata, Barrett's esophagus, Dieulafoy lesions, angiodysplasia, gastric antral vascular ectasia, and radiation proctitis."

Primary Outcome Measure Information:

Title

Percent of patients who have histologically cleared high-grade squamous intraepithelial lesions (HSIL) at the SCJ at 12 months as measured by HRA

Description

Histologic clearance of all HSIL within the ETZ on a patient and lesion basis at 12 months from first RFA

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Persistence of treated HSIL index lesions

Time Frame

3 months post RFA

Title

Time Frame

12 months

Title

Percent of patients who have histologically cleared low-grade squamous intraepithelial lesions (LSIL) at the SCJ at 12 months as measured by HRA

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 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 3 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 Exclusion Criteria: 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 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 3 months prior to the 0 month RFA visit (other than cauterization or excision of condylomata) 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 Concurrent disease requiring systemic immunosuppression therapy Concurrent malignancy requiring systemic therapy Life expectancy < 2 years

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Murad M Khan, BA

Phone

212-242-6500

murad.khan@icahn.mssm.edu

Facility Information:

Facility Name

Laser Surgery Care

City

New York

State/Province

New York

ZIP/Postal Code

10011

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stephen E Goldstone, MD

Phone

212-242-6500

goldstone.stephen@gmail.com

First Name & Middle Initial & Last Name & Degree

Stephen E Goldstone, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for High-Grade Anal Intraepithelial Neoplasia Using the BARRX™ Anorectal Wand

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