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NCT03554356 · ClinicalTrials.gov registry record · NA
Nitrous Oxide For Endoscopic Ablation of Refractory Barrett's Esophagus (NO FEAR-BE)
A NA study of Barrett Esophagus and Intestinal Metaplasia, sponsored by University of North Carolina, Chapel Hill.
- Active
- Registry status
- NA
- Development phase
- 70
- Enrollment target
- 11
- Study locations
NCT03554356 is a NA study of Barrett Esophagus and Intestinal Metaplasia that is active but no longer recruiting, run by University of North Carolina, Chapel Hill. The registered enrollment target is 70 participants, below the 3,563-participant average among 32 other Barrett Esophagus trials with a reported enrollment target (98% lower). The trial reports 11 study locations across 10 states.
The verdict
NCT03554356, a NA study of Barrett Esophagus and Intestinal Metaplasia, is active but no longer recruiting, sponsored by University of North Carolina, Chapel Hill.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
- 11
- Study locations
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,563-participant average among 32 other Barrett Esophagus trials with a reported enrollment target (98% lower). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
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.
NCT03554356 reports 11 study locations spanning 10 distinct geographic areas - top geographies include New York, Alabama, District of Columbia.
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.
What interventions are being tested in trial NCT03554356?
The interventions under investigation include: CryoBalloon Focal Ablation System (DEVICE).
Who is sponsoring clinical trial NCT03554356?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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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Related
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