At a glance
ClinicalIndex Comparison RecordN/ACompleted· 87 enrolled
Drug / intervention
ReActiv8 Implantable Stimulation Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
ReActiv8 Post Market Surveillance Registry for the ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain
In Brief
An observational study evaluating ReActiv8 Implantable Stimulation System for Chronic Low Back Pain. Completed, enrolled 87 participants across 5 sites.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Low Back Pain
CountriesGermany
Collaborators--
Timeline
N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 2017
Enrollment StartOct 2017
Primary CompletionMar 2023
Study CompletionDec 2023
TodayJul 2026
First PostedAug 21, 2017
Enrollment StartOct 9, 2017
Primary CompletionMar 20, 2023
Study CompletionDec 8, 2023
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 8.9 years ago
Interventions
ReActiv8 Implantable Stimulation Systemdevice
Implantable electrical stimulation system.