ReActiv8 Post Market Surveillance Registry (ReActiv8-C)

Mainstay Medical

Status: Completed

Conditions: Chronic Low Back Pain

Treatments: Device: ReActiv8 Implantable Stimulation System

Study type: Observational

Funder types: Industry

Identifiers

NCT03255200

950066

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design