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A Prospective Single Arm Multicenter Study Evaluating the Effects of Spray Cryotherapy in Patients with Persistent Local Esophageal Cancer
The primary objective is to study the effects of the truFreeze Spray Cryotherapy System in a population of subjects who have been diagnosed with persistent local esophageal cancer and who are not surgical candidates or have completed or declined systemic therapy.
Primary Endpoints:
Change from baseline EORTC QLQ-30 and OES-18 esophageal module at 14 days post cryotherapy procedure
Change from baseline Dysphagia Score at 14 days post spray cryotherapy procedure
Secondary Endpoints:
Time to additional interventional procedure(s) other than spray cryotherapy (e.g. stent placement)
Overall survival
Mean to change in the amount of residual tumor from baseline to follow-up cryospray delivery session as measured by endoscopic visualization (video and photographs) and tumor measurements
The primary objective is to study the effects of the truFreeze Spray Cryotherapy System in a population of subjects who have been diagnosed with persistent local esophageal cancer and who are not surgical candidates or have completed or declined systemic therapy.
Primary Endpoints:
Change from baseline EORTC QLQ-30 and OES-18 esophageal module at 14 days post cryotherapy procedure
Change from baseline Dysphagia Score at 14 days post spray cryotherapy procedure
Secondary Endpoints:
Time to additional interventional procedure(s) other than spray cryotherapy (e.g. stent placement)
Overall survival
Mean to change in the amount of residual tumor from baseline to follow-up cryospray delivery session as measured by endoscopic visualization (video and photographs) and tumor measurements
Recruitment Status
Past Studies