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 Barrett's Esophagus (BE).
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
78
no drug interventions specified
University of California -Irvine
Orange, California, United States
Norwalk Hospital
Norwalk, Connecticut, United States
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.
Time frame: 2 years post treatment
1.Eradication of all BE by 24 months after the final treatment. 2.The proportion of lesions that decreased in length by the 24-month follow-up. 3.The proportion of lesions where severity was downgraded by the 24-month follow-up.
Time frame: 2 years post treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Hoboken Universtiy Medical Center
Hoboken, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
Universtiy of North Carloina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
...and 6 more locations