6 results
5.1 Primary study objectives:5.1.1 SafetySafety of the device has been defined as 1. Device-related complications (24 hour perioperative and one month) 2. Procedure-related complications (24 hour perioperative and one month) 5.1.2…
Primary Objective: - To investigate the efficacy of Namisol® after a single dose of Δ9-THC on the experienced pain intensity (measured by the VASpain in rest and on movement) in patients with chronic pancreatitis.Secondary Objectives:- To…
The purpose of this Clinical Investigation Plan is to collect data on the safety and performance of the WiCS-LV system. It is designed to satisfy requirements for clinical data and post market clinical follow-up for the Active Implantable Medical…
Primary objective:- To investigate the analgesic efficacy of a stable dose treatment Namisol® in chronic pancreatitis patients suffering from abdominal pain. Analgesic efficacy is measured as mean difference in visual analogue scale (VAS) score (i.e…
Primary objective:*Evaluation of the efficacy of ECP002A (*9-THC) on spasticity in patients with MSSecondary objectives:*Evaluation of the efficacy of ECP002A (*9-THC) on pain in patients with MS*Evaluation of the tolerability of ECP002A (*9-THC) in…
The primary objective of this study is to evaluate the efficacy of CSL112 on reducing the risk of MACE (CV death, MI, or stroke) from the time of randomization through 90 days in subjects with ACS (diagnosed with STEMI or NSTEMI).