NCT00526786

Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus

A Prospective, Multi-center, Longitudinal Cohort Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus (LCS Dysplasia)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: CSA Medical, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of the CryoSpray Ablation System to treat esophageal low grade dysplasia (LGD) or high grade dysplasia (HGD) within Barrett's Esophagus (BE).

Detailed description

The study will consist of an estimated 200 subjects with HGD or LGD within BE who are deemed inoperable or refuse standard surgical treatment. A maximum of 20 investigational sites will participate with a maximum of ten subjects per site.

Conditions

• Barrett's Esophagus
• High Grade Dysplasia
• Low Grade Dysplasia

Interventions

Type	Name	Description
DEVICE	CryoSpray Ablation System (510(k) NO: K070893)	no drug interventions specified

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2007-09-10
• Last updated: 2014-03-14

Locations

16 sites across 1 country: United States