3 results
Primary Safety Endpoint:Safety will be assessed by incidence and severity of adverse events through 12-weeks (3 month) follow-up. Included in this assessment will be the proportion of subjects with any of the following outcomes between device…
Primary Objective: Therapeutic effect of electrical stimulation. Secondary Objective(s): (i) Side effects of electrical stimulation(ii) Effect on quality of life (iii) Effect of electrical stimulation on inflammatory and histologic parameters.
Primary Objective: The performance in preventing intraoperative hypotension of a MAP treatment alarm of 72 mmHg compared to the performance of the HPI alarm. Secondary Objectives: - The correlation between the MAP signal and HPI signal - The…