Trials / Unknown
UnknownNCT05941819
ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- Sponsor
- ONWARD Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this interventional study is to evaluate the safety and preliminary effectiveness of the ARC-IM Therapy to improve hemodynamic management in people with sub-acute or chronic spinal cord injury. Participants will be implanted with the ARC-IM Thoracic System which aim to deliver, at the low thoracic level, targeted epidural electrical stimulation that will support natural hemodynamic control.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ARC-IM Thoracic System implantation | Implantation of the ARC-IM Thoracic Lead on the low thoracic level of the spinal cord and implantation of the ARC-IM IPG in the abdominal region |
Timeline
- Start date
- 2023-09-05
- Primary completion
- 2025-09-30
- Completion
- 2025-09-30
- First posted
- 2023-07-12
- Last updated
- 2023-11-01
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT05941819. Inclusion in this directory is not an endorsement.