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C2 CryoBalloon™ 180 Ablation System Dose De-escalation Study.
Sponsor: Pentax Medical
Summary
The primary objective is to determine the safety, performance and efficacy of the C2 CryoBalloon 180 Ablation System ("CryoBalloon 180") used at decreasing doses in treatment 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 Dose Response Using the C2 CyroBalloon™ 180 Ablation System for the Treatment of Dysplastic Barrett's Esophagus.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2023-01-16
Completion Date
2026-12-01
Last Updated
2025-01-13
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 (5)
AMC Medical Research B.V.
Amsterdam, Netherlands
UMC Groningen
Groningen, Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
UMC Utrecht
Utrecht, Netherlands