5 results
This is a feasibility study of the Balloon-based Focal Cryoablation System to assess safety and performance in patients with a Barretts esophagus
Part 1To evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple intravenous doses of FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) and FEP-TAZ 3 g (2 g cefepime + 1 g tazobactam) administered every 8 hours (q8h) in healthy adult…
The primary objective of this randomized controlled clinical study is to evaluate the peri-procedural safety and potential effectiveness (mechanistic effect) of implanting the IASD System II in heart failure patients with an LV ejection fraction…
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…
The primary objective of this randomized controlled clinical trial is to evaluate the clinical efficacy and safety of the IASD System II in symptomatic heart failure patients with an LV ejection fraction >=40%, and elevated left sided filling…