Nitrous Oxide For Endoscopic Ablation of Refractory Barrett's Esophagus (NO FEAR-BE) (NCT03554356) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Nitrous Oxide For Endoscopic Ablation of Refractory Barrett's Esophagus (NO FEAR-BE)
United States70 participantsStarted 2018-09-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Percentage of all treated Subjects with complete eradication of all intestinal metaplasia (CEIM) within 12 months of enrollment.
Timeframe: 12 months
2
Percentage of all treated subjects with complete eradication of dysplasia (CED) within 12 months of enrollment
Timeframe: 12 months
3
Incidence of CryoBalloon-related serious adverse events
✕. 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.