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ReActiv8 Post Market Surveillance Registry

NCT03255200 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 87

Last updated 2024-10-16

Study results available
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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

  • Chronic Low Back Pain

Interventions

DEVICE

ReActiv8 Implantable Stimulation System

Implantable electrical stimulation system.

Sponsors & Collaborators

  • Mainstay Medical

    lead INDUSTRY

Principal Investigators

  • Stefan Schu, MD · SANA Klinikum Duisburg

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-09
Primary Completion
2023-03-20
Completion
2023-12-08

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03255200 on ClinicalTrials.gov