Clinical Trials Directory

Trials / Terminated

TerminatedNCT01156675

Study Evaluating the Safety and Effectiveness of the FLEXUS(TM) Interspinous Spacer

A Prospective Randomized Clinical Investigation of the FLEXUS(TM) Interspinous Spacer: A Pivotal Study

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
215 (actual)
Sponsor
Globus Medical Inc · Industry
Sex
All
Age
50 Years
Healthy volunteers
Not accepted

Summary

The purpose of this investigation is to evaluate the safety and effectiveness of the FLEXUS™ Interspinous Spacer as compared to the XSTOP® Spacer for the treatment of patients who are suffering from lumbar spinal stenosis at one or two contiguous levels.

Conditions

Interventions

TypeNameDescription
DEVICEFLEXUS(TM) Interspinous SpacerTreatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
DEVICEXSTOP® Interspinous SpacerTreatment of lumbar spinal stenosis with the XSTOP® Spacer

Timeline

Start date
2008-06-01
Primary completion
2015-07-01
Completion
2015-07-01
First posted
2010-07-05
Last updated
2018-06-01
Results posted
2018-04-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01156675. Inclusion in this directory is not an endorsement.

Study Evaluating the Safety and Effectiveness of the FLEXUS(TM) Interspinous Spacer (NCT01156675) · Clinical Trials Directory