CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 391 enrolled
Drug / intervention
Superion™ Interspinous Spacer +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.

Search/NCT00692276
NCT00692276N/ACompleted
CompareCT.gov

A Prospective, Multi-Center, Randomized Study Comparing the VertiFlex® Superion™ Interspinous Spacer (ISS) to the X-STOP® Interspinous Process Decompression (IPD®) System in Patients With Moderate Lumbar Spinal Stenosis

Boston Scientific Corporation·interventional·Posted Jun 6, 2008·Updated Nov 16, 2020

In Brief

A clinical study evaluating Superion™ Interspinous Spacer and X-STOP® IPD® Device for Lumbar Spinal Stenosis and Intermittent Claudication. Completed, enrolled 391 participants across 32 sites.

Detailed Summary

The proposed prospective, multi-center, randomized clinical trial is designed to evaluate the safety and effectiveness of the Superion™ ISS compared to the X-STOP® IPD® device in healthy adults suffering from at least 6 months of moderate spinal stenosis symptoms who have been unresponsive to conservative care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLumbar Spinal Stenosis, Intermittent Claudication
CountriesUnited States
CollaboratorsVertiFlex, Incorporated

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 6, 2008
Enrollment StartJun 1, 2008
Primary CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 8.7 yearsPosted 18.1 years ago

Interventions

Superion™ Interspinous Spacerdevice

Implantation of interspinous process spacer to treat lumbar spinal stenosis

X-STOP® IPD® Devicedevice

Implantation of interspinous process spacer to treat lumbar spinal stenosis