Status:
COMPLETED
Neurogenic Intermittent Claudication Evaluation Study
Lead Sponsor:
Medtronic Spinal and Biologics
Conditions:
Spinal Stenosis
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief 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...
Detailed Description
The NICE study is a Multicenter Prospective Randomized Controlled Clinical Trial to Evaluate the Effectiveness and Safety of the Aperius™ PercLID™System Versus Standalone Decompressive Surgery in Dege...
Eligibility Criteria
Inclusion
- Presence of symptomatic DLSS
- Presence of NIC
- Patient would be candidate for Standalone Decompressive Surgery
- Patient has signed Informed Consent form (ICF)
- Patient is 21 years old or older
Exclusion
- Previous lumbar surgery
- Patient is candidate for instrumented Decompressive Surgery
- Patient has back pain without leg pain
- Degenerative Spondylolisthesis greater than grade 1 (Meyerding)
- Symptomatic DLSS at more than 2 levels in the lumbar region
- Spinal stenosis is present at L5-S1 level
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT00905359
Start Date
January 1 2010
End Date
April 1 2015
Last Update
February 10 2017
Active Locations (19)
Enter a location and click search to find clinical trials sorted by distance.
1
Pindara Specialist Suite
Benowa, Queensland, Australia, 4217
2
Ziekenhuis St. Jan - Orthopedie
Bruges, Belgium, 8000
3
Clinique Parc Leopold - Neurochirurgie
Brussels, Belgium, 1040
4
CHU Tivoli - Neurochirurgie
La Louvière, Belgium, 7100