Condition: Spinal Cord Injuries · Blood Pressure Disorders · Sponsor: ONWARD Medical, Inc.
Empower BP is a pivotal, interventional, multicenter, prospective, randomized, controlled double-blinded study to evaluate the safety and effectiveness of the ARC-IM System in managing symptomatic blood pressure instability in individuals with chronic SCI (\>1 year after SCI). The primary effectiveness outcome will be evaluated through subject-reported ADFSCI and seated blood pressure assessments at 3 months post-implant. Following a baseline screening period and the surgical implantation of the ARC-IM System, subjects will be randomized with a 2:1 ratio into an active or control arm for 3 months. All the subjects will undergo therapy activation sessions (into either Group 1: active intervention, or Group 2: intervention aimed to mimic the active intervention without the active component) within 21 days of the surgical implant and will then commence independent at-home use of ARC-IM Therapy. At the 3 Month timepoint, after all assessments are conducted, all subjects will transition to the open-label period in order to receive the active version of the ARC-IM System in an open-label fashion. All subjects will undergo therapy programming sessions following Month 3.
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
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| University of Arkansas for medical Sciences | Little Rock, Arkansas, United States | Recruiting |
| Craig Hospital | Englewood, Colorado, United States | Recruiting |
| University of Miami | Miami, Florida, United States | Recruiting |
| Shepherd Center / Emory University | Atlanta, Georgia, United States | Recruiting |
| UofL Health - Frazier Rehabilitation Institute | Louisville, Kentucky, United States | Recruiting |
| VA Louisville | Louisville, Kentucky, United States | Recruiting |
| Kennedy krieger Institute | Baltimore, Maryland, United States | Recruiting |
| Spaulding Rehabilitation | Cambridge, Massachusetts, United States | Recruiting |
| Mayo clinic | Rochester, Minnesota, United States | Recruiting |
| Columbia University Irving Medical Center/ New York-Presbyterian Hospital | New York, New York, United States | Recruiting |
| James J. Peters VA Medical Center | The Bronx, New York, United States | Recruiting |
| Oregon Health & Science University | Portland, Oregon, United States | Recruiting |
+ 1 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07147296