RecruitingNot ApplicableNCT05740189

CBAS180 De-escalation Study

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

Sponsor

Koen Munters

Enrollment

62 participants

Start Date

Feb 19, 2023

Study Type

INTERVENTIONAL

Conditions

Cryotherapy Ablation Therapy Barrett's Esophagus Cryoballoon Ablation

Summary

Evaluate the efficacy and safety of the C2 CryoBalloon 180° Ablatie Systeem (CBAS180) at decremental doses for the treatment of dysplastic Barrett's epithelium.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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.

Exclusion Criteria10

Esophageal stenosis preventing advancement of a therapeutic endoscope.
Any endoscopically visualized lesion such as ulcers, masses or nodules. Neoplastic nodules must first be treated with ER ≥6 weeks prior to planned treatment under this protocol.
Prior ER of \>2cm in length and/or \>50% of the esophageal lumen circumference.
History of locally advanced (\>sm1) esophageal cancer.
History of esophageal varices.
Prior distal esophagectomy.
Active esophagitis LA grade B or higher.
Severe medical comorbidities precluding endoscopy.
Uncontrolled coagulopathy.
Pregnant or planning to become pregnant during period of study.

Interventions

DEVICEC2 CryoBalloon 180° Ablation System

The C2 CryoBalloon 180° Ablation System is a cryosurgical device with a nitrous oxide cooled balloon probe that is compatible with upper gastrointestinal therapeutic endoscopes.