At a glance
ClinicalIndex Comparison RecordN/ACompleted· 180 enrolled
Drug / intervention
Totalis +1 moredevice
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 Prospective, Multi-center, Randomized Controlled Double-Blind Trial Evaluating the VertiFlex® Totalis™ Direct Decompression System Versus a Sham Comparator Surgical Procedure in Patients With Lumbar Spinal Stenosis
In Brief
A clinical study evaluating Totalis and Comparator Surgical Procedure for Lumbar Spinal Stenosis. Completed, enrolled 180 participants across 19 sites.
Detailed Summary
The purpose of this study is to determine safety and effectiveness, as measured by changes in pain, disability, patient satisfaction, and claudicatory symptoms, at 6 months following treatment with the Totalis™ Direct Decompression System or Sham Comparator Surgical Procedure in patients with lumbar spinal stenosis
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLumbar Spinal Stenosis
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 2014
Enrollment StartMay 2014
Primary CompletionJan 2017
TodayJul 2026
First PostedMar 5, 2014
Enrollment StartMay 1, 2014
Primary CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 12.3 years ago
Interventions
Totalisdevice
Comparator Surgical Procedureprocedure