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Neurogenic Intermittent Claudication Evaluation Study

NCT00905359 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2017-02-10

Study results available
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Summary

The objective of the NICE study is to provide clinical evidence proving that the Aperius™ PercLID™ System is safe and non-inferior to standalone decompressive surgery with regards to clinical outcomes in patients suffering from Degenerative Lumbar Spinal Stenosis with Neurogenic Intermittent Claudication, relieved by flexion.

Conditions

  • Spinal Stenosis

Interventions

PROCEDURE

Aperius™ PercLID™ System

Aperius™ PercLID™ System: implantation with the Interspinous Process Device Aperius.

PROCEDURE

Standalone Decompressive Surgery

Lumbar decompressive surgery without instrumentation or fusion

Sponsors & Collaborators

  • Medtronic Spinal and Biologics

    lead INDUSTRY

Principal Investigators

  • Jean-Charles Le Huec, Prof. · CHU Pellegrin Tripode

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2014-09-30
Completion
2015-04-30

Countries

  • Australia
  • Belgium
  • France
  • Germany
  • Iceland
  • Italy
  • Poland
  • Singapore
  • Sweden
  • United Kingdom

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 NCT00905359 on ClinicalTrials.gov