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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: Active NA study of Barrett Esophagus and Intestinal Metaplasia, sponsored by University of North Carolina, Chapel Hill.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

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

FieldValue
Enrollment Target 70 participants
Start Date 2018-09-04
Est. Completion 2027-08
Phase NA

What the registry record for NCT03554356 still lists

NCT03554356 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 3,563-participant average among 32 other Barrett Esophagus trials with a reported enrollment target (98% lower).

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 lists 11 locations in 10 states (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.

Similar trials for Barrett Esophagus

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03554356's enrollment target sits among peer trials

70 23rd of 32 higher than 10 of 32 other Barrett Esophagus trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Barrett Esophagus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03554356, the US trial registry maintained by the National Library of Medicine. NCT03554356 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.