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C2 CryoBalloon™ 180 Ablation System Dose De-escalation Study.
Sponsor: Merit Medical Systems, Inc.
Summary
The primary objective is to determine the safety and efficacy of the C2 CryoBalloon 180 Ablation System ("CryoBalloon 180") used at decreasing doses in ablation naïve patients with low- or high-grade dysplastic Barrett's Esophagus (BE) or with residual BE after resection of dysplasia or early adenocarcinoma.
Official title: Clinical Trial To Evaluate Safety and Efficacy of the C2 CyroBalloon™ 180 Ablation System for the Treatment of Dysplastic Barrett's Esophagus: CBAS180 De-escalation Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
62
Start Date
2023-01-16
Completion Date
2026-12-18
Last Updated
2026-05-22
Healthy Volunteers
No
Conditions
Interventions
C2 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.
Locations (6)
AMC Medical Research B.V.
Amsterdam, Netherlands, Netherlands
Catharina Hospital Eindhoven
Eindhoven, Netherlands, Netherlands
UMC Groningen
Groningen, Netherlands, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands, Netherlands
UMC Utrecht
Utrecht, Netherlands, Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands