NCT01293448

Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Pentax Medical · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Barrett's Esophagus
• Esophageal Cancer

Interventions

Type	Name	Description
DEVICE	Cryoballoon Ablation	Device: CryoBalloon Ablation System(TM) C2 Therapeutics Inc. received FDA market clearance for the CryoBalloon Ablation System on September 29, 2010. 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." (K101825)

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-02-10
• Last updated: 2022-04-28

Locations

4 sites across 2 countries: United States, Netherlands