Clinical Trial to Evaluate Safety and Efficacy of the C2 Cryoballoon 180° Ablation System for the Treatment of Dysplastic Barrett's Esophagus: CBAS180 De-escalation Study
Evaluate the efficacy and safety of the C2 CryoBalloon 180° Ablatie Systeem (CBAS180) at decremental doses for the treatment of dysplastic Barrett's epithelium.
• Flat type BE esophagus, with an indication for ablation therapy, defined as:
‣ Diagnosis of LGD or HGD in BE (confirmed by BE expert pathologist) or;
⁃ Residual BE with any grade of dysplasia after endoscopic resection (by means of EMR or ESD) to treat non-flat BE, ≥6 weeks prior to enrolling the patient to this study. The ER pathology should indicate endoscopic treatment (i.e. only mucosal invasion or limited submucosal invasion (sm1), no lymphovascular infiltration, free vertical resection margins and not poorly differentiated).
• Prague Classification Score of C≤3 and M≥1.
• Patients should be ablation-naïve, meaning they have not undergone any previous endoscopic ablation therapy of the esophagus.
• Older than 18 years of age at time of consent.
• Fit for endoscopic therapy per institution's standards.
• Provides written informed consent on the IRB-approved informed consent form.
• Willing and able to comply with follow-up requirements.