The STEPS - Totalis™ Trial

Status Completed

Clinical Trial 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

Clinical Trial Description

Subjects suffering from symptoms of neurogenic intermittent claudication secondary to a radiographically-confirmed diagnosis of central canal stenosis, with or without mild or moderate lateral recess stenosis, at one or two levels from L1 to L5 who meet all inclusion/exclusion criteria, including ≥6 months of non-operative management.

Patients included in the clinical investigation will return for follow-up visits at 1 week for safety evaluation, and at 6 weeks, 3 months, 6 months, 12 months, 18 months and 24 months post-treatment to collect data for evaluation of safety and effectiveness. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02079038
Study type	Interventional
Source	VertiFlex, Incorporated
Contact
Status	Completed
Phase	N/A
Start date	May 2014
Completion date	January 2017

View Details

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