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ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury

The ARC-IM System helps manage blood pressure issues from spinal cord injury.

Recruiting
18-75 years
All
Phase N/A
Study Overview: This research is testing a new device called the ARC-IM System to help manage blood pressure problems in people who have had a spinal cord injury for over a year. Blood pressure instability can be uncomfortable or dangerous, especially when sitting or standing. Study Process: Participants will undergo surgery for the ARC-IM System implant and will be divided into two groups. One group will receive active treatment, while the other will receive a placebo-like treatment. After three months, all participants will receive the active treatment. Eligibility: Participants must be 18-75 years old and have specific blood pressure issues due to a spinal cord injury that occurred at least a year ago.
  • Participation involves a surgical implant and follow-up visits to monitor progress.
  • Subjects will need to manage without certain blood pressure medications for 30 days before joining.
  • If you need daily help from a caregiver, they must be present during study visits.
Safety Note: Some conditions, like heart problems or pregnancy, mean you cannot join. Check with your doctor if you are eligible and consider the commitment before participating.
Study details
    Spinal Cord Injuries
    Blood Pressure Disorders

NCT07147296

ONWARD Medical, Inc.

17 October 2026

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