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CBAS180 De-escalation Study

NCT05740189 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2024-10-01

No results posted yet for this study

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.

Conditions

  • Barrett's Esophagus
  • Ablation Therapy
  • Cryotherapy
  • Cryoballoon Ablation

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

  • Pentax Medical

    collaborator INDUSTRY

  • Koen Munters

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-19
Primary Completion
2025-05-31
Completion
2026-01-15
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 NCT05740189 on ClinicalTrials.gov