Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium

Not Applicable

Completed

• Conditions: Barrett's Esophagus
• Interventions: Device: C2 CryoBalloon Focal Ablation System

• Registration Number: NCT02249975
• Lead Sponsor: Pentax Medical

Brief Summary

The purpose of this study is to assess the efficacy and performance of the C2 Focal Cryoablation System in patients with BE.

Detailed Description

The purpose of this study is to assess the efficacy and performance of the C2 Focal Cryoablation System in patients with BE. The study will involve up to 50 subjects with each subject receiving cryoablation therapy of all visible BE using the C2 System Focal Ablation System. Length of ablation will be 10 seconds. The ablations will be performed on Barrett's epithelium with a maximal length of 6 cm.

At the time of endoscopic follow up, biopsies of the treated area will be taken and submitted for analysis according to Histopathology Protocol.

This study is:

* Prospective

* Multi-center

* Non-randomized

Study Timeline

• Study First Submitted: 2014-09-24
• Study First Submitted QC: 2014-09-25
• Study First Posted: 2014-09-26
• Study Start: 2015-01
• Primary Completion: 2016-12-29
• Study Completion: 2017-10-04
• Status Verified: 2018-02
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
C2 CryoBalloon Focal Ablation System	C2 CryoBalloon Focal Ablation System	Cryoballoon ablation will be performed on patients with Barrett's Esophagus.

Primary Outcome Measures

Name	Time	Method
Presence of residual Barrett's Esophagus	12 weeks	Efficacy (% of) Barrett's epithelium fully converted to squamous epithelium upon cryoablation

Secondary Outcome Measures

Name	Time	Method
Patient Pain	post-procedure through 12 week follow-up	Patient is asked to rate any pain in the treatment area or with swallowing
Device Performance	12 weeks	All device performance will be reported
Incidence of adverse events	12 weeks	All adverse events will be reported

Trial Locations

Locations (2)

St. Antonius Hospital; 🇳🇱 Nieuwegein, Netherlands

Academic Medical Center Amsterdam; 🇳🇱 Amsterdam, Netherlands