Clinical trials: Neurogenic Claudication
Spinal Stenosis
Neurogenic Intermittent Claudication Evaluation Study
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…
- Trial name
- NICE (NCT00905359)
- Testing
- Aperius™ PercLID™ System, Standalone Decompressive Surgery
- Where
- 19 sites in Australia, Belgium and 8 more
- Volunteers
- 163 people
- Sponsor
- Medtronic Spinal and Biologics
Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
The MOTION Study - Treatment of LSS With the MILD Procedure
Prospective, multicenter, randomized controlled clinical study examining functional improvement in lumbar spinal stenosis (LSS) patients with neurogenic claudication who are treated with the MILD procedure plus conventional…
- Trial name
- NCT03610737
- Testing
- MILD Procedure, Conventional Medical Management (CMM)
- Where
- 18 sites in United States
- Volunteers
- 155 people
- Sponsor
- Vertos Medical, Inc.
Lumbar Spinal Stenosis, Spondylolisthesis, Grade 1
Pedicle Osteotomy for Stenosis Trial
This is a pivotal Randomized Clinical trial to compare the safety and effectiveness of the Pedicle Lengthening Osteotomy Procedure with implantation of the Altum® Device to open surgical decompression and Transforaminal Lumbar…
- Conditions
- Lumbar Spinal Stenosis, Spondylolisthesis, Grade 1, Neurogenic Claudication
- Trial name
- POST (NCT03381677)
- Testing
- Pedicle Lengthening Osteotomy with Altum® Device, Control
- Where
- United States
- Volunteers
- 344 people
- Sponsor
- Innovative Surgical Designs
Spinal Stenosis, Lumbar Region With Neurogenic Claudication
Assessing Superion Clinical Endpoints vs. Decompression
PURPOSE: The primary purpose of this study is to demonstrate that the Composite Clinical Success of the study group receiving the Superion® IDS is not inferior to the success rate observed in the study group treated by direct…
- Trial name
- ASCEND (NCT03048955)
- Testing
- Superion® IDS, Direct decompression Surgery
- Where
- 5 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- VertiFlex, Incorporated
Lumbar Spinal Stenosis
Effects of X-STOP® Versus Laminectomy Study
To determine if the effectiveness of the X-STOP® implant is equivalent (non-inferior) to that of conventional laminectomy in patients with lumbar spinal stenosis as measured by the Zurich Claudication Questionnaire.
- Trial name
- EXELS (NCT00558129)
- Testing
- X-STOP®, Laminectomy
- Sponsor
- Medtronic Spine LLC
Spinal Lumbar Stenosis, Claudication, Intermittent
Evaluation of Safety and Effectiveness of Lobster Dynamic Interspinous Spacer in Lumbar Spinal Stenosis
The aim of this study is to demonstrate the safety and effectiveness of the Lobster interspinous spacer device for the treatment of Lumbar Spinal Stenosis in comparison to an SSED-based performance goal.
- Trial name
- LB2CT01 (NCT05587465)
- Testing
- Lobster Device
- Where
- Italy
- Volunteers
- 210 people
- Sponsor
- Diametros Medical srl
Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
The MiDAS ENCORE Study
Study Objective: To compare patient outcomes following treatment with either the MILD procedure or epidural steroid injections (ESIs) in patients with painful lumbar spinal stenosis exhibiting neurogenic claudication and having…
- Trial name
- NCT02093520
- Testing
- MILD Procedure, Epidural Steroid Injection
- Where
- 12 sites in United States
- Volunteers
- 302 people
- Sponsor
- Vertos Medical, Inc.
Spinal Stenosis
Intermittent Neurogenic Claudication Treatment With APERIUS®
The primary purpose of the study is to measure the change in severity of symptoms and ability to function in every day activities in patients suffering from degenerative lumbar spinal stenosis after treatment with the Aperius®…
- Trial name
- INCA (NCT00887744)
- Testing
- Aperius® Percutaneous Interspinous Spacer
- Where
- 12 sites in Belgium, Germany and 1 more
- Volunteers
- 162 people
- Sponsor
- Medtronic Spinal and Biologics
Lumbar Spinal Stenosis
Condition of Approval Study
This prospective, multicenter longitudinal five-year study of X-STOP PEEK usage in LSS patients is designed to supplement pre-market safety and effectiveness data with information on longer-term device performance in a population…
- Trial name
- COAST (NCT00517751)
- Testing
- X-STOP PEEK
- Where
- 23 sites in United States
- Volunteers
- 176 people
- Sponsor
- Medtronic Spine LLC
Intermittent Neurogenic Claudication (INC) as a Result of Spinal Stenosis
A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis
A Randomized, Blinded Comparison of Surgical Intervention with the Coflex® Interspinous Implant versus Surgical Decompression for Patients with Intermittent Neurogenic Claudication caused by Lumbar Stenosis
- Trial name
- FELIX (NCT01727752)
- Testing
- Decompression
- Where
- 13 sites in Netherlands
- Volunteers
- 386 people
- Sponsor
- Paradigm Spine