6 results
Primary• To evaluate the safety of using a modified staged treatment algorithm at 3*months following the second placement of AeriSeal foam treatment in subjects with severe emphysema.Secondary• To evaluate lung function, exercise tolerance and,…
The objective of this study is to evaluate the safety and performance of the ROX Coupler in subjects with resistant hypertension.
Primary:1) Feasibility: Evidence of targeted lung volume reduction (TLVR) on CT scan at 6 weeks and 3 months follow up after endobronchial valve placement.Secondary:2) Safety: The number and type of procedure-related (Serious) Adverse events within…
Primary objective: To investigate the safety of Mim8 prophylaxis in children with haemophilia A with or without FVIII inhibitors.Secondary objectives• To investigate the efficacy of Mim8 prophylaxis in children with haemophilia A with or without…
To assess the efficacy of Revita® DMR for improving HbA1c to <= 7% without the need of insulin in subjects with T2D compared to sham.To assess the efficacy of DMR versus Sham on improvement in Glycemic, Hepatic and Cardiovascular endpoints.
This study consists of the following objections:- To evaluate feasibility, safety, and efficacy of endoscopic DMR Treatment Paradigm 1 (compared to sham)- To evaluate feasibility, safety, and efficacy of re-treatment with DMR at 24 weeks (compared…