Spots Global Cancer Trial Database for Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System
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Trial Identification
Brief Title: Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System
Official Title: Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System for the Treatment of Patients With Previously Untreated Dysplastic Barrett's Epithelium
Study ID: NCT02514525
Conditions
Interventions
Study Description
Brief Summary: To evaluate the efficacy and safety of the CryoBalloon Focal Ablation System for the treatment of previously-untreated ("treatment naïve") Barrett's Esophagus (BE)
Detailed Description: Coldplay III is a multi-center, prospective study that will provide evidence of the efficacy and safety of the System in treatment of patients with previously untreated (treatment naïve) low grade dysplasia (LGD) or high grade dysplasia (HGD) BE. Subjects may have a maximum of five (5) ablation treatment sessions during their 12 months of study participation to achieve complete eradication of their dysplastic BE and intestinal metaplasia. As many ablations as needed to treat the dysplastic areas are allowed in each treatment session at the discretion of the investigator.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UC Irvine, Orange, California, United States
Sarasota Memorial Hospital, Sarasota, Florida, United States
University of Chicago, Chicago, Illinois, United States
John Hopkins, Baltimore, Maryland, United States
Mayo Clinic, Rochester, Minnesota, United States
Northwell Health, Manhasset, New York, United States
New York Presbyterian Hospital-Columbia University Medical Center, New York, New York, United States
University of North Carolina School of Medicine, Chapel Hill, North Carolina, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Contact Details
Name: Marcia Canto, MD
Affiliation: Johns Hopkins Medical Center
Role: PRINCIPAL_INVESTIGATOR
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