A Phase 2 interventional study of BARRX™ Anorectal Wand in HSIL, High Grade Squamous Intraepithelial Lesions, Anal Cancer and HPV-Related Squamous Cell Carcinoma, sponsored by Stephen E. Goldstone. Status unknown at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-05.
Sponsored by Stephen E. Goldstone · Phase 2, Interventional, and Treatment
Among 44 studies in Squamous Intraepithelial Lesions with a site in United States — 7 open to participants now, 8 under way, 1 of them phase 3. Squamous Intraepithelial Lesions · United States.
Among the 44 studies in Squamous Intraepithelial Lesions with a site in United States, this one is the 18th largest by planned enrollment of the 39 interventional ones that give a count, is one of 5 that started in 2017, is one of 19 in phase 2, and was the 29th registered.
104 studies on the registry are indexed under Squamous Intraepithelial Lesions; 36 are open to participants now.
Browse Squamous Intraepithelial Lesions studies →7 of the 44 studies in Squamous Intraepithelial Lesions with a site in United States are open now. Recruiting first, the newest first:
Mayo Clinic · Sites in United States
Ages 18+ · Women only
University of California, San Francisco · Sites in United States, Puerto Rico
Ages 21+
The Center for Clinical and Cosmetic Research · Sites in United States
Ages 18+
The Center for Clinical and Cosmetic Research · Sites in United States
Ages 18+
Frantz Viral Therapeutics, LLC · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 23 Squamous Intraepithelial Lesions studies recruiting now, 11 (48%) set no upper age limit and 11 (48%) stop at 75 or younger; 3 take children under 18; 7 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
44 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 21 · Phase 3 6 · Phase 4 2
First in 2003; this study’s year is marked. 5 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 70 is close to the median of 71 across 73 interventional studies indexed under Squamous Intraepithelial Lesions.
Median enrollment 48 across the 39 interventional studies, 195 across the 5 observational. Of the 34 that completed or were terminated, 19 (56%) have results posted.
This tab as a report to print or save as PDF → With an account.
14 of 44 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Stephen E. Goldstone as lead sponsor.
Stephen E. Goldstone has 1 study filed under Squamous Intraepithelial Lesions — fewer than ten, so there is no comparison to draw.
5 of the studies in Squamous Intraepithelial Lesions with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05381597Phase 3Boston University5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin Cancer | 2027-06 |
| NCT07931664The Center for Clinical and Cosmetic ResearchEvaluating Photodynamic Therapy Used to Treat Cutaneous Squamous Cell Carcinoma in Situ (isSCC) on the Face, Upper Extremities & Trunk. | 2026-11 |
| NCT06206564Frantz Viral Therapeutics, LLCArtesunate Ointment for the Treatment of Anal HSIL in HIV-negative Participants | 2026-12-31 |
| NCT07886203Mayo ClinicEvaluation of a Point-of-Care, AI-Powered Spectroscopy Device for Triage of Suspicious Vulvar Lesions: A Pilot Study | 2027-09-30 |
| NCT06949800University of California, San FranciscoCASCADE 2002: PROTECT Study, "PRObiotics to TrEat Anal preCancer Trial | 2027-10-31 |
Add all 5 to your calendar (.ics) → With an account.
Among the 44 studies in Squamous Intraepithelial Lesions with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
HRA 2 to 8 weeks prior to the 0 month RFA visit yielding one or more flat, non- condylomatous -proven HSILs that are
Eligible treatment zone (ETZ) is defined as
If positive
Exclusion Criteria:
History of topical therapy (e.g. Imiquimod, 5-FU, Trichloroacetic acid) within the
ETZ within 3 months prior to the 0 month RFA visit
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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."
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
Time frame: 12 months
Persistence of treated HSIL index lesions
Time frame: 3 months post RFA
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).
Time frame: 12 months
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
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Start is estimated for Oct 2017; primary completion for Oct 2019, 24 months later.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Squamous Intraepithelial Lesions →