4 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…
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…
Primary objective:To demonstrate superiority of Qutenza over low-dose capsaicin control in change from baseline to Week 12 in the 24-hr average pain intensity in subjects with PSNP.Secondary objective:• To demonstrate superiority of Qutenza over low…