ReActiv8 Post Market Surveillance Registry
CompletedNCT03255200
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- ReActiv8 Post Market Surveillance Registry for the ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain
- Conditions
- Interventions
- Device: ReActiv8 Implantable Stimulation System
- Sponsor
- Mainstay Medical
- Start date
- 2017-10-09
- Primary completion
- 2023-03-20
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Germany
- Total sites listed
- 5
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Meet the Indications for ReActiv8 2. Willing to sign the Informed Consent for the Registry 3. Age ≥ 18 years Exclusion Criteria: 1\. Subjects will be excluded from the Registry if they are contraindicated for ReActiv8.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03255200