Nitrous Oxide For Endoscopic Ablation of Refractory Barrett's Esophagus (NO FEAR-BE) (NCT03554356)
🩺 Plain-English Summary (8th-Grade Level)
A multicenter, prospective, single arm, non randomized clinical trial to evaluate the safety and efficacy of the C2 CryoBalloon Focal Ablation System (CbFAS) for the treatment of persistent dysplasia or intestinal metaplasia (IM) in the tubular esophagus after 3 or more radiofrequency ablations (RFA) for dysplastic BE, or \<50% eradication of Barrett's Esophagus (BE) after 2 RFA treatments.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (12 items) and avoid the listed exclusions (19 items).
Location: University of Alabama at Birmingham — Birmingham, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Residual BE Prague length measuring \>C3 or \>M8 after RFA treatment.
- Dysplasia or IM confined only to the gastric cardia.
- Pre-existing esophageal stenosis/stricture preventing advancement of a therapeutic endoscope during screening/baseline EGD. Subjects are eligible if the stenosis/stricture is dilated to at least 15mm, but baseline treatment may need to be delayed per protocol.
- Symptomatic, untreated esophageal strictures.
- 5\. Any endoscopically visualized abnormalities such as ulcers, masses, or nodules found in the BE during screening/baseline EGD. Subjects with nodular dysplasia or IMC identified during screening/baseline EGD may be treated with EMR or ESD and return for baseline treatment in this study at least 6 weeks later given that: 5.1. Follow-up endoscopy must be negative for nodular dysplasia (visually clear of nodular dysplasia).
- 2. Patients with IMC must be at low risk for recurrence, confirmed by EMR/ESD pathology results negative for: positive margin, \>T1a stage, poorly differentiated carcinoma, and lymphovascular invasion.
- EMR or ESD \< 6 weeks prior to baseline treatment.
- Untreated invasive esophageal malignancy, including margin-positive EMR/ESD.
- Active reflux esophagitis grade B or higher in the BE assessed during screening/baseline EGD.
- Severe medical comorbidities precluding endoscopy or limiting life expectancy to less than 2 years in the judgment of the endoscopist.
- Uncontrolled coagulopathy.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (11 Sites)
- University of Alabama at Birmingham — Birmingham, Alabama
- Georgetown University — Washington D.C., District of Columbia
- Johns Hopkins University — Baltimore, Maryland
- Mayo Clinic Rochester — Rochester, Minnesota
- Northwell Health — Lake Success, New York
- Columbia University — New York, New York
- UNC Chapel Hill — Chapel Hill, North Carolina
- University Hospitals Cleveland Medical Center — Cleveland, Ohio
- Geisinger Clinic — Danville, Pennsylvania
- Medical University of South Carolina — Charleston, South Carolina
- UTHealth Science Center/Herman Memorial — Houston, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.