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The purpose of the study is to evaluate the clinical safety and feasibility of the NL-Prowâ„¢ Interspinous Spacer implant and insertion procedure in the treatment of lumbar spinal stenosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NL-Prow interspinous spacer implant | Device | Interspinous spacer implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accurate placement of the interspinous spacer confirmed by fluoroscopy | Procedure completion |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in leg and or back pain and in walking capability compared to baseline | One year | |
| Any device and or procedure related adverse events or complications | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zdenek Novak, MD, PhD | St. Anne's University Hospital Brno, Czech Republic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurosurgery department, St. Anne's University Hospital | Brno | 656 91 | Czechia |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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