Trials / Completed
CompletedNCT02577354
ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain
ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain (ReActiv8-B)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 204 (actual)
- Sponsor
- Mainstay Medical · Industry
- Sex
- All
- Age
- 22 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this trial is to evaluate the safety and efficacy of ReActiv8 for the treatment of adults with Chronic Low Back Pain when used in conjunction with medical management.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ReActiv8 Implantable Stimulation System (Patient Appropriate Stimulation) | ReActiv8 implanted and configured to deliver stimulation at a patient-appropriate level, and participants instructed to deliver stimulation in two 30-minute sessions per day. |
| DEVICE | ReActiv8 Implantable Stimulation System (Low Stimulation) | ReActiv8 implanted and configured to deliver low stimulation, and participants instructed to deliver stimulation in two 30-minute sessions per day. |
Timeline
- Start date
- 2016-08-01
- Primary completion
- 2018-11-01
- Completion
- 2024-01-01
- First posted
- 2015-10-16
- Last updated
- 2025-02-27
- Results posted
- 2020-10-19
Locations
26 sites across 5 countries: United States, Australia, Belgium, Netherlands, United Kingdom
Source: ClinicalTrials.gov record NCT02577354. Inclusion in this directory is not an endorsement.