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NCT03255200 Clinical Trial

ReActiv8 Post Market Surveillance Registry

Chronic Low Back Pain Clinical Trial

— ReActiv8-C  

Official title:
ReActiv8 Post Market Surveillance Registry for the ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03255200
Other study ID # 950066
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 9, 2017
Est. completion date December 2023

Study information
Verified date December 2023
Source Mainstay Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 50
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• ReActiv8 Implantable Stimulation System
Implantable electrical stimulation system.

Locations
Country Name City State
Germany BG Klinikum Bergmannstrost Halle
Germany Medizinisches Versorgungszentrum Steinburg gGmbH Itzehoe
Germany Katholisches Klinikum Koblenz Koblenz
Germany Klinikum Magdeburg Magdeburg
Germany Orthopadisches Krankenhaus Schloss Werneck Werneck Balthasar-Neumann

Sponsors (1)
Lead Sponsor Collaborator
Mainstay Medical

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Low Back Pain - NRS Change in NRS compared to Baseline 90 days, 180 days, 1 year, 2 years post Activation
Secondary Serious Adverse Device Effects Through 2 years post Activation
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