Trials / Completed
CompletedNCT03255200
ReActiv8 Post Market Surveillance Registry
ReActiv8 Post Market Surveillance Registry for the ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 87 (actual)
- Sponsor
- Mainstay Medical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To gather data on the long-term safety of ReActiv8 and identify any residual risks by reporting all Serious Adverse Device Effects as well as performance and health care utilization through two years post-implant.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ReActiv8 Implantable Stimulation System | Implantable electrical stimulation system. |
Timeline
- Start date
- 2017-10-09
- Primary completion
- 2023-03-20
- Completion
- 2023-12-08
- First posted
- 2017-08-21
- Last updated
- 2024-10-16
- Results posted
- 2024-10-16
Locations
5 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT03255200. Inclusion in this directory is not an endorsement.