Ignite Creation Date:
2024-05-05 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00526786
Status:
TERMINATED
Last Update Posted:
2014-03-14
First Post:
2007-09-05
Brief Title:
Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barretts Esophagus
Sponsor:
CSA Medical Inc
Organization:
CSA Medical Inc
Study Overview
Official Title:
A Prospective Multi-center Longitudinal Cohort Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barretts Esophagus LCS Dysplasia
Status:
TERMINATED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business Reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICE
Brief 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 Barretts 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None