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HSIL, High Grade Squamous Intraepithelial LesionsPhase 2NCT03302858

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

A Phase 2 study testing BARRX™ Anorectal Wand in people with HSIL, High Grade Squamous Intraepithelial Lesions and Anal Cancer, run by Stephen E. Goldstone at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
What is being tested?
BARRX™ Anorectal Wand
Type of treatment
Medical device
How many people
70 participants
Where
1 siteUnited States
Study dates
Oct 2017to Oct 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Murad M Khan, BA contact

212-242-6500

murad.khan@icahn.mssm.edu

United States1 site, 1 recruiting

  • Laser Surgery Care

    New York, New York, 10011

    Stephen E Goldstone, MD, 212-242-6500, goldstone.stephen@gmail.com

    Stephen E Goldstone, MD

    Recruiting

Other trials in United States

About this study

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.

Being tested
BARRX™ Anorectal Wand
Medical subject headings
Squamous Intraepithelial Lesions, Anus Neoplasms, Papillomavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BARRX™ Anorectal WandDevice

    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."

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 months

Secondary outcomes (3)

  1. Persistence of treated HSIL index lesions

    Measured: 3 months post RFA

  2. 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).

    Measured: 12 months

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2017
  2. Study startOct 2017 (estimated)
  3. Primary completionOct 2019 (estimated)
  4. Study completionOct 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03302858
Sponsor's protocol ID
01-2017
Status last verified
Oct 2017
First submitted
20 Sep 2017
Last updated
5 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BARRX™ Anorectal Wand in people with HSIL, High Grade Squamous Intraepithelial Lesions and Anal Cancer, run by Stephen E. Goldstone at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Murad M Khan, BA (212-242-6500, murad.khan@icahn.mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of patients who have histologically cleared high-grade squamous intraepithelial lesions (HSIL) at the SCJ at 12 months as measured by HRA (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03302858.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2017.

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