A STUDY OF CRYOSPRAY ABLATIONTM USING SURGICAL RESECTION SPECIMENS TO DETERMINE TREATMENT EFFECT, DEPTH OF INJURY, AND SIDE EFFECTS IN THE ESOPHAGUS (CSA Depth 3)
The proposed study is a single center study consisting of no more than 10 subjects who are
undergoing scheduled esophagectomy for reasons unrelated to the study. Subjects will be
divided into 2 Groups in a sequential fashion based on the time of enrollment (Subject 1 in
Group1, Subject 2 in Group 2, Subject 3 in Group1, Subject 4 in Group 2, etc). Potential
study subjects will be referred from clinical practice. After entry into the study with
written informed consent, subjects will be scheduled for the EGD with cryospray ablation
treatment 7 days prior to the expected esophagectomy date.
All subjects will receive narcotic analgesics to control symptoms.
Endpoints related to pathology will be assessed by two independent reviewers, one from the
Institution's Department of Pathology, and one from an independent Pathology lab chosen by
the sponsor. The reviewers will evaluate the pathology slides to assess maximal extent of
depth of injury, side effects, and pathological changes associated with CSA. All reviewers
will be blinded to the treatment conditions of the specimens.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary effectiveness endpoints are the treatment effect and depth of injury in healthy tissue using endoscopic cryospray therapy in esophagectomy subjects.
End of Study
Afonso Ribeiro, M.D.
University of Miami Sylvester Comprehensive Cancer Center
United States: Institutional Review Board
|University of Miami, Sylvester Comprehensive Cancer Center||Miami, Florida 33136|