Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium

Pentax Medical4 sites in 2 countries21 target enrollmentDecember 2010

ConditionsBarrett's Esophagus Esophageal Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Barrett's Esophagus
Sponsor: Pentax Medical
Enrollment: 21
Locations: 4
Primary Endpoint: Treatment effect
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate a cryoablation technique used to ablate human esophageal mucosa.

Detailed Description

The purpose of this study is to evaluate the histological results of a cryoablation technique used to ablate human esophageal mucosa. The performance and safety of the cryoablation technique will also be evaluated.

Registry

clinicaltrials.gov

Start Date

December 2010

End Date

January 2012

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Pentax Medical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient must have a minimum of 2.0 cm of non-ulcerated, non-inflammatory columnar-lined esophagus or squamous esophageal lined tissue suitable for ablation. A patient may be treated with up to 2 zones of ablation.
•Patient is 18 to 80 years of age at the time of consent (inclusive).
•Patient has provided written Informed Consent Form (IFC) using a form that has been approved by the Institution's reviewing IRB/EC.
•Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements.
•Patient's esophagectomy is clinically necessary due to reasons unrelated to this study.
•Patient is deemed operable per standard institutional criteria.

Exclusion Criteria

•Patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to IFC, post treatment instructions or follow-up guidelines.
•Patient refuses or is unable to provide written informed consent. - -
•Patient has or is currently undergoing endoscopic ablation therapy within 4 cm from the proposed treatment area including, but not limited to cryospray therapy, laser treatment, photodynamic therapy, multi-polar electro coagulation, endoscopic mucosal resection, radiofrequency ablation or argon plasma coagulation.
•Patient has esophageal narrowing limiting access to the intended site of ablation.
•Patient is undergoing or has recently undergone chemotherapy (within 15 days or WBC below normal by institutional criteria or standards).
•Patient is undergoing or has recently undergone radiation therapy which involved the esophagus (within 15 days or WBC below normal by institutional criteria or standards).