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

NCT02249975 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-04-28

No results posted yet for this study

Summary

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

Conditions

  • Barrett's Esophagus

Interventions

DEVICE

C2 CryoBalloon Focal Ablation System

The C2 Focal Cryoablation Device will be used for the treatment of islands of BE in real patient care. Ablation at 10 seconds will be tested and post-ablation symptoms related to the Cryoballoon Focal Ablation will be recorded. At 12 weeks, the patient will receive a follow-up endoscopy and biopsy samples will be taken. Biopsy samples will be evaluated for the presence of residual Barrett's Esophagus. Through evaluation of the histological results, treatment parameters for the ablation of human esophageal epithelium will be better understood. Evaluations include, but are not limited to the following: * Device malfunctions * Adverse events * Patient Pain * Histological evaluation of treatment zone at 12 weeks for presence of residual Barrett's Esophagus.

Sponsors & Collaborators

  • Pentax Medical

    lead INDUSTRY

Principal Investigators

  • Jacques Bergman, MD, PhD · Academic Medical Centre (Amsterdam)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-12-29
Completion
2017-10-04

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 NCT02249975 on ClinicalTrials.gov