A Prospective, Multi-Center, Longitudinal Cohort Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus (LCS Dysplasia)
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The eradication of LGD and HGD within BE at 24 months after the final treatment. The primary safety endpoint is the incidence of all adverse events.
2 years post treatment
Yes
Bruce Greenwald, M.D.
Principal Investigator
University of Maryland
United States: Institutional Review Board
16-00016-00
NCT00526786
September 2007
September 2011
Name | Location |
---|---|
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Boston Medical Center | Boston, Massachusetts 02118 |
University of Pittsburgh Medical Center | Pittsburgh, Pennsylvania 15213 |
Baylor University | Waco, Texas |
Duke University Medical Center | Durham, North Carolina 27710 |
H. Lee Moffitt Cancer Center | Tampa, Florida 33612 |
Thomas Jefferson University Hospital | Philadelphia, Pennsylvania 19131 |
University of Maryland Medical Center | Baltimore, Maryland 21201-1595 |
Norwalk Hospital | Norwalk, Connecticut 06856 |
Columbia University Medical Center | New York, New York 10032 |
University of California -Irvine | Orange, California 92868 |
Hoboken Universtiy Medical Center | Hoboken, New Jersey 07030 |
Universtiy of North Carloina at Chapel Hill | Chapel Hill, North Carolina 27599 |
Lancaster Reginal Medical Center | Lancaster, Pennsylvania 17604 |