๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-09

Nitrous Oxide For Endoscopic Ablation of Refractory Barrett's Esophagus (NO FEAR-BE) (NCT03554356)

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: University of North Carolina, Chapel Hill

๐Ÿฉบ 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: Review the eligibility criteria below.

Location: University of Alabama at Birmingham โ€” Birmingham, Alabama

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (11 Sites)

  • University of Alabama at Birmingham โ€” Birmingham, Alabama
  • Georgetown University โ€” Washington D.C., District of Columbia
  • Johns Hopkins University โ€” Baltimore, Maryland
  • Mayo Clinic Rochester โ€” Rochester, Minnesota
  • Northwell Health โ€” Lake Success, New York
  • Columbia University โ€” New York, New York
  • UNC Chapel Hill โ€” Chapel Hill, North Carolina
  • University Hospitals Cleveland Medical Center โ€” Cleveland, Ohio
  • Geisinger Clinic โ€” Danville, Pennsylvania
  • Medical University of South Carolina โ€” Charleston, South Carolina
  • UTHealth Science Center/Herman Memorial โ€” Houston, Texas

๐Ÿ’ฐ 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 ยง 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.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—