ReActiv8 Post Market Surveillance Registry
ReActiv8-C
1 other identifier
observational
87
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2017
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2017
CompletedFirst Posted
Study publicly available on registry
August 21, 2017
CompletedStudy Start
First participant enrolled
October 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 8, 2023
CompletedResults Posted
Study results publicly available
October 16, 2024
CompletedOctober 16, 2024
October 1, 2024
5.4 years
August 15, 2017
May 30, 2024
October 14, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Low Back Pain - Numeric Pain Rating (NRS) Scale
Change in low back pain Numerical Rating Scale (NRS) compared to Baseline. The NRS is an 11-point scale where 0 means no pain at all and 10 means worst imaginable pain. Patients were asked to rate their average low back pain in the last 24 hours. Lower scores or reduction in score means an improvement or reduction in pain.
90 days, 180 days, 1 year, 2 years post Activation
Secondary Outcomes (1)
Serious Adverse Device Effects
Through 2 years post Activation
Interventions
Implantable electrical stimulation system.
Eligibility Criteria
The study population for this registry is persons with chronic low back pain who are indicated for ReActiv8.
You may qualify if:
- Meet the Indications for ReActiv8
- Willing to sign the Informed Consent for the Registry
- Age ≥ 18 years
You may not qualify if:
- \. Subjects will be excluded from the Registry if they are contraindicated for ReActiv8.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mainstay Medicallead
Study Sites (5)
Orthopadisches Krankenhaus Schloss Werneck
Werneck, Balthasar-Neumann, 97440, Germany
BG Klinikum Bergmannstrost
Halle, Germany
Medizinisches Versorgungszentrum Steinburg gGmbH
Itzehoe, Germany
Katholisches Klinikum Koblenz
Koblenz, Germany
Klinikum Magdeburg
Magdeburg, Germany
Limitations and Caveats
This study was an open-label registry with no formal statistical hypotheses. The sample size was based on the desire to gain a sufficient amount of representative data with the device in the post-market setting. It provides real-world data on the safety and performance of the device but is not a robust clinical trial, and thus, has the potential for bias.
Results Point of Contact
- Title
- Director, Clinical Affairs
- Organization
- Mainstay Medical
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Schu, MD
SANA Klinikum Duisburg
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2017
First Posted
August 21, 2017
Study Start
October 9, 2017
Primary Completion
March 20, 2023
Study Completion
December 8, 2023
Last Updated
October 16, 2024
Results First Posted
October 16, 2024
Record last verified: 2024-10