Status:
COMPLETED
CryoSpray Ablation (TM) GI Patient Registry
Lead Sponsor:
CSA Medical, Inc.
Conditions:
Barrett's Esophagus
Esophageal Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to create a patient registry to collect and analyze post-510K approval information on subjects treated endoscopically with the CryoSpray Ablation™ System.
Detailed Description
The proposed registry is a prospective, multi-center study of patients that are being currently undergoing CryoSpray Ablation™. It will also be used to catalogue retrospective data from records of pat...
Eligibility Criteria
Inclusion
- The study population consists of patients who are being treated, or were treated, with the CryoSpray Ablation™ System for malignant or pre-malignant conditions of the esophagus, including:
- Barrett's esophagus with or without dysplasia
- Squamous dysplasia of the esophagus
- Esophageal cancer, any stage
Exclusion
- Subjects with esophageal lesions whose pathology was not one of the above.
- Subjects with one of the above conditions who were not treated with the CryoSpray Ablation™ System.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT00747448
Start Date
May 1 2009
End Date
June 1 2013
Last Update
February 2 2016
Active Locations (6)
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1
The Scripps Research Institute
La Jolla, California, United States, 92037
2
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
3
Syosset Hospital
Lake Success, New York, United States, 10042
4
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, United States, 27599