ACTIVE_NOT_RECRUITING

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

Conditions

Barrett Esophagus Intestinal Metaplasia Esophageal Dysplasia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-09-04

Study Completion:2026-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03554356

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 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. 2. Prior treatment with RFA who meet either of the following criteria at the enrolling EGD: 2.1. 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. 3. 18 or older years of age at time of consent. 4. Provides written informed consent. 5. Willing to undergo an alternative approved standard of care treatment for their condition. 6. Willing and able to comply with study requirements for follow-up. 7. No prior history of balloon or spray cryotherapy esophageal treatment. Prior APC is allowable.	1. Residual BE Prague length measuring \>C3 or \>M8 after RFA treatment. 2. Dysplasia or IM confined only to the gastric cardia. 3. 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. 4. Symptomatic, untreated esophageal strictures. 5. 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). 5.2. 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. 6. EMR or ESD \< 6 weeks prior to baseline treatment. 7. Untreated invasive esophageal malignancy, including margin-positive EMR/ESD. 8. Active reflux esophagitis grade B or higher in the BE assessed during screening/baseline EGD. 9. Severe medical comorbidities precluding endoscopy or limiting life expectancy to less than 2 years in the judgment of the endoscopist. 10. Uncontrolled coagulopathy. 11. 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. 12. Active fungal esophagitis. 13. Known portal hypertension, visible esophageal varices, or history of esophageal varices. 14. General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation. 15. Pregnant or planning to become pregnant during period of study participation. 16. Patient refuses or is unable to provide written informed consent. 17. Prior esophageal surgery with the exception of uncomplicated nissen fundoplication.

Inclusion Criteria

Exclusion Criteria

1. 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.
2. Prior treatment with RFA who meet either of the following criteria at the enrolling EGD:
2.1. 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.
3. 18 or older years of age at time of consent.
4. Provides written informed consent.
5. Willing to undergo an alternative approved standard of care treatment for their condition.
6. Willing and able to comply with study requirements for follow-up.
7. No prior history of balloon or spray cryotherapy esophageal treatment. Prior APC is allowable.

1. Residual BE Prague length measuring \>C3 or \>M8 after RFA treatment.
2. Dysplasia or IM confined only to the gastric cardia.
3. 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.
4. Symptomatic, untreated esophageal strictures.
5. 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).
5.2. 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.
6. EMR or ESD \< 6 weeks prior to baseline treatment.
7. Untreated invasive esophageal malignancy, including margin-positive EMR/ESD.
8. Active reflux esophagitis grade B or higher in the BE assessed during screening/baseline EGD.
9. Severe medical comorbidities precluding endoscopy or limiting life expectancy to less than 2 years in the judgment of the endoscopist.
10. Uncontrolled coagulopathy.
11. 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.
12. Active fungal esophagitis.
13. Known portal hypertension, visible esophageal varices, or history of esophageal varices.
14. General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation.
15. Pregnant or planning to become pregnant during period of study participation.
16. Patient refuses or is unable to provide written informed consent.
17. Prior esophageal surgery with the exception of uncomplicated nissen fundoplication.

Contacts and Locations

Principal Investigator

Nicholas J Shaheeen, MD, MPH

PRINCIPAL_INVESTIGATOR

UNC Chapel Hill

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35294

United States

Georgetown University

Washington, District of Columbia, 20057

United States

Johns Hopkins University

Baltimore, Maryland, 21205

United States

Mayo Clinic Rochester

Rochester, Minnesota, 55905

United States

Northwell Health

Lake Success, New York, 11042

United States

Columbia University

New York, New York, 10032

United States

UNC Chapel Hill

Chapel Hill, North Carolina, 27599

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

United States

Geisinger Clinic

Danville, Pennsylvania, 17822

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

UTHealth Science Center/Herman Memorial

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

Nicholas J Shaheeen, MD, MPH, PRINCIPAL_INVESTIGATOR, UNC Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-09-04

Study Completion Date2026-08

Study Record Updates

Study Start Date2018-09-04

Study Completion Date2026-08

Terms related to this study

Additional Relevant MeSH Terms

Barrett Esophagus
Intestinal Metaplasia
Esophageal Dysplasia