4 results
The primary objectives are to determine the diagnostic performance of gadofosveset-enhanced T1-weighted MR imaging for the discrimination between pN0 and pN+ patients for both primary staging and restaging after chemoradiotherapy and to determine…
The study is intended to (1) confirm the reduced x-ray shadow of the MicroTEE (S8-3t) probe, and to asses whether this results in a more delayed first pull back or a reduction in the number of pull backs or not; and (2) to evaluate the feasibility…
The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.
Primary: To compare the pharmacokinetics (PK) of the once daily (QD) and once weekly (QW) formulations of setmelanotideSecondary Objectives:To assess the safety of the QW formulation of setmelanotide with up to 6 months (26 weeks) of drug…