7 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:Compare the efficacy of BMS-936557 versus placebo for induction of clinical remission (defined as Mayo score * 2 points with no individual subscore > 1 point) at Week 7 (IP-50).Secondary objective* Compare the efficacy of…
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…
This study aims to validate the Corsano CardioWatch 287-2 for the continuous monitoring of heart rate at <= 4 bpm root mean squared error (RMSE); interbeat intervals at <= 50 ms RMSE; breathing rate at <= 2 brpm RMSE; and…
Primary objective: To compare the number of episodes of atrial fibrillation detected by the Corsano CardioWatch 287-2 during 28 days of use with the number of episodes of atrial fibrillation detected by conventional Holter monitoring during 48 hours…
This study aims to evaluate the Corsano Cardiowatch 287-2 for heart rate, heart rate variability (RR intervals), oxygen saturation, respiratory rate, and blood pressure during strenuous activities such as High-Intensity Interval Training (HIIT).…
To assess the ability to track blood pressure decrease measured by the Corsano CardioWatch 287-2 after a period of 28 days of antihypertensive drug treatment initiation, uptitration or change in antihypertensive drugs.