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

NCT03554356 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 18-0388
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 11

Brief 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

Esophageal Dysplasia; Barrett Esophagus; Intestinal Metaplasia

Outcome Measures

Primary Outcomes (3)

• Percentage of all treated Subjects with complete eradication of all intestinal metaplasia (CEIM) within 12 months of enrollment.

  12 months

• Percentage of all treated subjects with complete eradication of dysplasia (CED) within 12 months of enrollment

  Stratified by prior type of ablation treatment and baseline grade (LGD or HGD) will also be reported.

  12 months

• Incidence of CryoBalloon-related serious adverse events

  Relation of serious adverse events to CryoBalloon device will be assessed by the PI

  12 months

Secondary Outcomes (19)

• Technical success rate

  At end of treatment period, up to 12 months

• Procedure success rate

  At end of treatment period, up to 12 months

• Progression rate

  At end of treatment period, up to 12 months

• Survival curve analysis - time to CEIM

  At end of treatment period, up to 12 months

• Survival curve analysis - time to progression

  At end of treatment period, up to 12 months

Study Arms (1)

Cryoballoon Focal Ablation System (CbFAS) Treatment

EXPERIMENTAL

Subjects undergoing CbFAS treatment as part of their clinical care for their condition.

Device: CryoBalloon Focal Ablation System

Interventions

CryoBalloon Focal Ablation System DEVICE

CryoBalloon Focal Ablation System

Cryoballoon Focal Ablation System (CbFAS) Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:
• History of at least 3 RFA treatments, with one or more of the following:
• Residual BE Prague \>=C1
• Residual BE \>=M1
• One or more islands of residual BE \>=1 cm in diameter
• 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.
• 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.
• \. 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).
• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Johns Hopkins University: collaborator
• Merit Medical Systems, Inc.: collaborator

Study Sites (11)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20057, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Northwell Health

Lake Success, New York, 11042, United States

Location

Columbia University

New York, New York, 10032, United States

Location

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Geisinger Clinic

Danville, Pennsylvania, 17822, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

UTHealth Science Center/Herman Memorial

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Nicholas J Shaheeen, MD, MPH

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 13, 2018
• Study Start: September 4, 2018
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (11)