At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 162 enrolled
Drug / intervention
Aperius® Percutaneous Interspinous Spacerdevice
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.
A Multicenter, Post Marketing Clinical Follow-up Study to Evaluate the Safety and Effectiveness of the Minimally Invasive Device APERIUS® in Degenerative Lumbar Spinal Stenosis With Symptomatic Neurogenic Intermittent Claudication
In Brief
A Phase 4 clinical trial evaluating Aperius® Percutaneous Interspinous Spacer for Spinal Stenosis. Completed, enrolled 162 participants across 12 sites in 3 countries.
Detailed Summary
The primary purpose of the study is to measure the change in severity of symptoms and ability to function in every day activities in patients suffering from degenerative lumbar spinal stenosis after treatment with the Aperius® device.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Stenosis
CountriesBelgium, Germany, United Kingdom
Collaborators--
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2006
First PostedApr 2009
Primary CompletionMay 2009
Study CompletionMar 2010
TodayJul 2026
First PostedApr 24, 2009
Enrollment StartNov 1, 2006
Primary CompletionMay 1, 2009
Study CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 17.2 years ago
Interventions
Aperius® Percutaneous Interspinous Spacerdevice
Implantation of the Aperius® device