4 results
1. Overall survival (primary efficacy endpoint)2a. Efficacy: progression-free survival (PFS), overall response rate (ORR = CR + PR), and a clincal benefit rate (CBR) will be evaluated as CR + PR + SD for at least 3 months.2b. Safety: adverse events…
This is a feasibility study of the Balloon-based Focal Cryoablation System to assess safety and performance in patients with a Barretts esophagus
This study will evaluate the efficacy of the CbFAS with the optimal safe dose on the conversion of Barrett's epithelium to healthy squamous cell epithelium in a larger cohort. Furthermore, the device performance of the improved CbFAS will be…
Evaluate the safety and performance of the Virtue* Sirolimus Eluting Balloon for the treatment of in-stent restenosis (ISR) in native coronary arteries.