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CryoSpray Ablation (TM) GI Patient Registry - NCT00747448-02903(Clinical Trial 486159)



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City:  Providence
State:  
RI
Zip Code: 02903
Conditions: Barrett's Esophagus With or Without Dysplasia - Squamous Dysplasia of the Esophagus - Esophageal Cancer (Any Stage)
Purpose: 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.
Study summary: 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 patients already treated with the device. A maximum of 40 investigational sites will participate in this study.
Criteria: Inclusion Criteria: - 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 Criteria: - 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.
Study is available at: Rhode Island Hospital
Providence, RI 02903
United States

Primary Contact:
Jan Clark
Email: JClark3@Lifespan.org
Phone: 401-444-7344

Secondary Contact:
Karen McKenzie
Email: kmckenzie@csamedical.com
Phone: 443-524-9673
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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