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

NCT01633411 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 39

Last updated 2022-04-28

No results posted yet for this study

Summary

This is a feasibility study without a primary study hypothesis or statistical comparison.

Conditions

  • Barrett's Esophagus

Interventions

DEVICE

Focal Cryoballoon Ablation System - 6 seconds

Ablation of Barrett's Esophagus using a Focal Cryoballoon ablation catheter. The System is a Class II device "intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications."

DEVICE

Focal Cryoballoon Ablation System - 8 seconds

Ablation of Barrett's Esophagus using a Focal Cryoballoon ablation catheter. The System is a Class II device "intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications."

DEVICE

CryoBalloon Focal Ablation System - 10 seconds

Ablation of Barrett's Esophagus using the Focal CryoBalloon Ablation System. The System is a Class II device "intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications".

Sponsors & Collaborators

  • Pentax Medical

    lead INDUSTRY

Principal Investigators

  • Bas L Weusten, MD, pHD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Eligibility

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

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-05-31
Completion
2014-06-30

Countries

  • United States
  • 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 NCT01633411 on ClinicalTrials.gov