Status:
COMPLETED
Postmarket Registry for Evaluation of the Superion® Spacer
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Lumbar Spinal Stenosis
Eligibility:
All Genders
45+ years
Brief Summary
To gather evidence documenting the performance and clinical outcomes associated with treatment of moderate degenerative lumbar spinal stenosis using the Superion® Indirect Decompression System (IDS).
Detailed Description
To gather evidence documenting the performance and clinical outcomes associated with treatment of moderate degenerative lumbar spinal stenosis using the Superion® IDS in patients ≥45 years of age suff...
Eligibility Criteria
Inclusion
- male and female patients ≥45 years of age
- symptoms of neurogenic intermittent claudication and a confirmed diagnosis of moderate degenerative lumbar stenosis at one or two contiguous levels from L1 to L5
- meeting the labeled indications for use of the Superion® Indirect Decompression System (IDS)
Exclusion
- not contraindicated as described in the labeled indications for use
Key Trial Info
Start Date :
November 28 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
1674 Patients enrolled
Trial Details
Trial ID
NCT04087811
Start Date
November 28 2016
End Date
March 1 2021
Last Update
July 6 2023
Active Locations (66)
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1
(ACT) Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States, 35235
2
HOPE Research Institute
Phoenix, Arizona, United States, 85018
3
HOPE Research Institute
Scottsdale, Arizona, United States, 85018
4
NuVation Pain Group
Buena Park, California, United States, 90621