2 results
Approved WMOCompleted
The primary objective of this prospective, two-arm, multicenter, post-market study is to evaluate safety through the incidence of reported device-related adverse events (AEs) through 30 days following use of the Endo GIA* Reinforced Reload with Tri-…
Approved WMOWill not start
Safety:* Evaluate the safety of AVXS-101 through incidence of adverse events (AEs) and/or serious adverse events (SAEs)* Evaluate the safety of AVXS-101 based on the change from baseline in clinical laboratory parametersEfficacy objectives will be…