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ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury
NCT07147296 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ONWARD Medical, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07147296 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Colorado, Florida, Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07147296?
This trial is sponsored by ONWARD Medical, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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