3 results
The objective of this study is to evaluate the safety and device performance of the Portaero Pneumostoma System to create and maintain a transthoracic pneumostoma in patients with severe emphysema and hyperinflation.
The primary objectives are to:1) Adapt and optimize sequences and protocols to enable acquisitions during exercise with MRI and/or surface EMG.2) Perform a study in healthy volunteers using the sequences and protocols developed in 1) to correlate MR…
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…