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

NCT03311451 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Barrett Esophagus

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.

Sponsors & Collaborators

  • Merit Medical Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Bas LA Weusten, MD, PhD · St. Antonius Ziekenhuis, Niewegein The Netherlands

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-16
Primary Completion
2026-06-18
Completion
2026-12-18
FDA Device
Yes

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03311451 on ClinicalTrials.gov