3 results
The study objectives are:- to characterize the biotransformation pathways, the routes and rates of excretion, and total recovery of the 14C-labeled research medication and its radiolabeled metabolites- to characterize the pharmacokinetics (PK) of…
The primary objective of this second phase study is to estimate the occurrence of anastomotic leakage when the C-seal is used.Secondary objectives are:* Feasibility of applying the C-seal, especially considering the improved attachement to the…
Demonstrate that the observed incidence of procedure and/or device related incidence of new stroke (excludes transient ischemic attack) within 30 days of an ablation procedure (index or reablation) with the Phased RF System is less than 1.8% with…