3 results
Primary clinical investigation objectives[Safety]The primary safety objective of the clinical investigation is to provide data that demonstrates safety of the device, defined as < 8.3% serious adverse device effects, up to 6 weeks following…
Primary Objective • To determine whether ITCA 650 is non-inferior either to empagliflozin or to glimepiride in reducing glycosylated hemoglobin A1c (HbA1c) or weight in patients with T2D following 65 weeks of treatment. The non-inferiority margins…
Primary Objective: Assess the ability of MRCP+ and LMS to detect change in total biliary volume and cT1 value, 8 weeks after endoscopic treatment of dominant strictures, by a clinical decision rule.Secondary Objective(s): Comparison of baseline MRCP…