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

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

Plain Language Summary

Simplified for easier understanding

This study is testing a de-escalation approach to treating Barrett's esophagus with dysplasia (a condition where abnormal cells in the food pipe can progress to cancer) using a reduced-dose radiofrequency ablation (a technique that uses heat to destroy abnormal cells) protocol. **You may be eligible if...** - You are over 18 years old - You have flat Barrett's esophagus with low-grade or high-grade dysplasia confirmed by an expert pathologist, OR you have remaining dysplastic Barrett's esophagus after a prior endoscopic resection - You have not had any previous ablation (burning/destroying) treatment of the esophagus - You are healthy enough for endoscopic procedures **You may NOT be eligible if...** - You have a blockage in the esophagus that prevents passage of a scope - You have visible ulcers, masses, or nodules in the esophagus - You have a history of locally advanced esophageal cancer - You have had esophageal varices or previous esophageal surgery - You have active severe esophagitis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(6)

Catharina Hospital

Eindhoven, North Brabant, Netherlands

UMC Groningen

Groningen, Provincie Groningen, Netherlands

Erasmus MC

Rotterdam, South Holland, Netherlands

St Antonius hospital

Nieuwegein, Utrecht, Netherlands

UMC Utrecht

Utrecht, Utrecht, Netherlands

Amsterdam UMC

Amsterdam, North Holland, Netherlands

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NCT05740189


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