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Investigating Superion™ In Spinal Stenosis

NCT00692276 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 391

Last updated 2020-11-16

Study results available
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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.

Conditions

  • Lumbar Spinal Stenosis
  • Intermittent Claudication

Interventions

DEVICE

Superion™ Interspinous Spacer

Implantation of interspinous process spacer to treat lumbar spinal stenosis

DEVICE

X-STOP® IPD® Device

Implantation of interspinous process spacer to treat lumbar spinal stenosis

Sponsors & Collaborators

  • VertiFlex, Incorporated

    collaborator INDUSTRY

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Roshini Jain · Boston Scientific Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00692276 on ClinicalTrials.gov