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

Running, not enrolling · Not applicable

Conditions studied: Barrett Esophagus, Intestinal Metaplasia, Esophageal Dysplasia

In brief

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 facts

Study ID

NCT03554356

Run by

University of North Carolina, Chapel Hill

People needed

70

Starts

2018-09-04

Expected to finish

2027-08-01

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of BE with LGD or HGD confirmed with biopsy, or resected intramucosal cancer (IMC) with low risk of recurrence defined as EMR/ESD pathology results negative for: positive margin, >T1a stage, poorly differentiated carcinoma, and lymphovascular invasion.
• Prior treatment with RFA who meet either of the following criteria at the enrolling EGD:
• 1. History of at least 3 RFA treatments, with one or more of the following:
• 2.1.1. Residual BE Prague >=C1
• 2.1.2. Residual BE >=M1
• 2.1.3. One or more islands of residual BE >=1 cm in diameter
• 2.1.4. Any residual dysplasia in tubular esophagus 2.2. History of at least 2 RFA treatments and < 50% eradication of BE, as judged by estimation of the treating physician.
• 18 or older years of age at time of consent.
• Provides written informed consent.
• Willing to undergo an alternative approved standard of care treatment for their condition.
• Willing and able to comply with study requirements for follow-up.
• No prior history of balloon or spray cryotherapy esophageal treatment. Prior APC is allowable.

You may not qualify if…

• Residual BE Prague length measuring >C3 or >M8 after RFA treatment.
• Dysplasia or IM confined only to the gastric cardia.
• Pre-existing esophageal stenosis/stricture preventing advancement of a therapeutic endoscope during screening/baseline EGD. Subjects are eligible if the stenosis/stricture is dilated to at least 15mm, but baseline treatment may need to be delayed per protocol.
• Symptomatic, untreated esophageal strictures.
• 5. Any endoscopically visualized abnormalities such as ulcers, masses, or nodules found in the BE during screening/baseline EGD. Subjects with nodular dysplasia or IMC identified during screening/baseline EGD may be treated with EMR or ESD and return for baseline treatment in this study at least 6 weeks later given that: 5.1. Follow-up endoscopy must be negative for nodular dysplasia (visually clear of nodular dysplasia).
• 2. Patients with IMC must be at low risk for recurrence, confirmed by EMR/ESD pathology results negative for: positive margin, >T1a stage, poorly differentiated carcinoma, and lymphovascular invasion.
• EMR or ESD < 6 weeks prior to baseline treatment.
• Untreated invasive esophageal malignancy, including margin-positive EMR/ESD.
• Active reflux esophagitis grade B or higher in the BE assessed during screening/baseline EGD.
• Severe medical comorbidities precluding endoscopy or limiting life expectancy to less than 2 years in the judgment of the endoscopist.
• Uncontrolled coagulopathy.
• Inability to hold use of anti-coagulation medications or non-aspirin anti-platelet agents (APAs) for the duration recommended per ASGE guidelines for a high-risk endoscopy procedure.
• Active fungal esophagitis.
• Known portal hypertension, visible esophageal varices, or history of esophageal varices.
• General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation.
• Pregnant or planning to become pregnant during period of study participation.
• Patient refuses or is unable to provide written informed consent.
• Prior esophageal surgery with the exception of uncomplicated nissen fundoplication.

Where it is running

• 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

Full record on ClinicalTrials.gov

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