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ACTIVE NOT RECRUITING
NCT03554356
NA

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

Sponsor: University of North Carolina, Chapel Hill

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2018-09-04

Completion Date

2027-08

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

DEVICE

CryoBalloon Focal Ablation System

CryoBalloon Focal Ablation System

Locations (11)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Georgetown University

Washington D.C., District of Columbia, United States

Johns Hopkins University

Baltimore, Maryland, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Northwell Health

Lake Success, New York, United States

Columbia University

New York, New York, United States

UNC Chapel Hill

Chapel Hill, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Geisinger Clinic

Danville, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

UTHealth Science Center/Herman Memorial

Houston, Texas, United States