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