Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Nitrous Oxide For Endoscopic Ablation of Refractory Barrett's Esophagus (NO FEAR-BE)
NCT03554356 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DEVICE CryoBalloon Focal Ablation System
Study Locations (11)
New York
- Northwell Health — Lake Success
- Columbia University — New York
Alabama
- University of Alabama at Birmingham — Birmingham
District of Columbia
- Georgetown University — Washington D.C.
Maryland
- Johns Hopkins University — Baltimore
Minnesota
- Mayo Clinic Rochester — Rochester
North Carolina
- UNC Chapel Hill — Chapel Hill
Ohio
- University Hospitals Cleveland Medical Center — Cleveland
Pennsylvania
- Geisinger Clinic — Danville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2018-09-04 |
| Est. Completion | 2027-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03554356
The ClinicalTrials.gov registry entry for NCT03554356 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 725 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Barrett Esophagus appearing as the primary indexed condition, and to 1 intervention — of which CryoBalloon Focal Ablation System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03554356 reports 11 study locations spanning 10 distinct geographic areas — top geographies include New York, Alabama, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03554356 about?
NCT03554356 is a clinical study titled "Nitrous Oxide For Endoscopic Ablation of Refractory Barrett's Esophagus (NO FEAR-BE)". 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...
What is the current status of trial NCT03554356?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 70 participants. The study started on 2018-09-04. Estimated completion is 2027-08.
What conditions does trial NCT03554356 study?
This clinical trial studies the following conditions: Barrett Esophagus, Intestinal Metaplasia, Esophageal Dysplasia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03554356?
The interventions under investigation include: CryoBalloon Focal Ablation System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03554356?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 725 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03554356 being conducted?
This trial has 11 study locations across Alabama, District of Columbia, Maryland, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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