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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

⁃ 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:

• 1.1. Residual BE Prague >=C1

• 1.2. Residual BE >=M1

• 1.3. One or more islands of residual BE >=1 cm in diameter

• 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.

Locations
United States
Alabama
University of Alabama at Birmingham
Recruiting
Birmingham
Washington, D.c.
Georgetown University
Not yet recruiting
Washington
Maryland
Johns Hopkins University
Recruiting
Baltimore
Minnesota
Mayo Clinic Rochester
Recruiting
Rochester
North Carolina
UNC Chapel Hill
Recruiting
Chapel Hill
New York
Northwell Health
Recruiting
Lake Success
Columbia University
Recruiting
New York
Icahn School of Medicine at Mount Sinai
Not yet recruiting
New York
Ohio
University Hospitals Cleveland Medical Center
Recruiting
Cleveland
Pennsylvania
Geisinger Clinic
Recruiting
Danville
South Carolina
Medical University of South Carolina
Recruiting
Charleston
Texas
UTHealth Science Center/Herman Memorial
Recruiting
Houston
Contact Information
Primary
Lindsay Cortright, MA
lindsay_cortright@med.unc.edu
919-445-4911
Backup
Susan Moist, MPH
susan_moist@med.unc.edu
919-918-5900
Time Frame
Start Date: September 4, 2018
Estimated Completion Date: December 2024
Participants
Target number of participants: 70
Treatments
Experimental: Cryoballoon Focal Ablation System (CbFAS) Treatment
Subjects undergoing CbFAS treatment as part of their clinical care for their condition.
Related Therapeutic Areas
Sponsors
Collaborators: PENTAX of America, Inc., Johns Hopkins University
Leads: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov

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