First Patient Enrolled in the SMILE Study, Sensible Medical Innovation’s Randomized Controlled Trial (RCT) Designed to Measure ReDS™ Technology Impact on Heart Failure Rehospitalizations
News Release excerpt provided by PR Newswire.
Sensible Medical Innovations, focused on the commercialization of a non-invasive thoracic fluid status monitor based on ReDS™ medical radar technology, today announced enrollment of the first patient in the SMILE study. SMILE is designed as a prospective, randomized, controlled, multi-center trial and is expected to enroll approximately 380 patients in 35 centers in the US. Its primary efficacy endpoint is the rate of recurrent Heart Failure re-hospitalization during the entire follow-up period of ReDS-guided fluid management. Additional endpoints include clinical outcomes and healthcare economics assessment. The first patient was enrolled at Ohio State University in Columbus Ohio by Dr. Rami Kawash, site principal investigator.
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Originally published October 20, 2015.
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