NCT01633411

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 39 (actual)
• Sponsor: Pentax Medical · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The purpose of this study is to assess the safety, feasibility, and performance of the C2 Focal Cryoablation Device in patients with Barrett's Esophagus (BE). At 6 to 8 weeks, the patient will receive a follow-endoscopy to assess stricture formation along with biopsy samples taken. Post-operative pain will be noted. Additionally, 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: * Deployment ease/scope compatibility. * Device malfunctions. * Time of catheter deployment. * Adverse events. * Stricture formation at 6 to 8 weeks. * Patient Pain. * Histological evaluation of treatment zone at 6 to 8 weeks for presence of residual Barrett's Esophagus.

Conditions

• Barrett's Esophagus

Interventions

Type	Name	Description
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".

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-05-01
• Completion: 2014-06-01
• First posted: 2012-07-04
• Last updated: 2022-04-28

Locations

8 sites across 2 countries: United States, Netherlands