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NCT07147296 · ClinicalTrials.gov registry record · NA
ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury
A NA study of Spinal Cord Injuries and Blood Pressure Disorders, sponsored by ONWARD Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 5
- Study locations
NCT07147296 is a NA study of Spinal Cord Injuries and Blood Pressure Disorders that is actively recruiting participants, run by ONWARD Medical. The registered enrollment target is 60 participants, roughly in line with the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target. The trial reports 5 study locations across 5 states.
The verdict
NCT07147296, a NA study of Spinal Cord Injuries and Blood Pressure Disorders, is actively recruiting participants, sponsored by ONWARD Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 5
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- PROCEDURE ARC-IM System Implantation
- DEVICE ARC-IM Therapy (Group 1)
- DEVICE ARC-IM Therapy (Group 2)
Study Locations (5)
Colorado
- Craig Hospital - Englewood
Florida
- University of Miami - Miami
Kentucky
- UofL Health - Frazier Rehabilitation Institute - Louisville
Massachusetts
- Spaulding Rehabilitation - Cambridge
Oregon
- Oregon Health & Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-10-17 |
| Est. Completion | 2029-03 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07147296
The ClinicalTrials.gov registry entry for NCT07147296 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target. The listed sponsor is ONWARD Medical, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Spinal Cord Injuries appearing as the primary indexed condition, and to 3 interventions - of which ARC-IM System Implantation is the first listed.
NCT07147296 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Colorado, Florida, Kentucky.
Frequently Asked Questions
What is clinical trial NCT07147296 about?
NCT07147296 is a clinical study titled "ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury". 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 effective...
What is the current status of trial NCT07147296?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2025-10-17. Estimated completion is 2029-03.
What conditions does trial NCT07147296 study?
This clinical trial studies the following conditions: Spinal Cord Injuries, Blood Pressure Disorders.
What interventions are being tested in trial NCT07147296?
The interventions under investigation include: ARC-IM System Implantation (PROCEDURE), ARC-IM Therapy (Group 1) (DEVICE), ARC-IM Therapy (Group 2) (DEVICE).
Who is sponsoring clinical trial NCT07147296?
This trial is sponsored by ONWARD Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07147296 being conducted?
This trial has 5 study locations across Colorado, Florida, Kentucky, Massachusetts, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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