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ENROLLING BY INVITATION
NCT03311451
NA

C2 CryoBalloon™ 180 Ablation System Dose De-escalation Study.

Sponsor: Pentax Medical

View on ClinicalTrials.gov

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

Interventions

DEVICE

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