Clinical trials: Lumbar
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.
Spondylosis, Cervical Spondylosis
ViBone in Cervical and Lumbar Spine Fusion
Assess clinical and radiographic outcomes in patients who undergo 1-3 level anterior cervical discectomy fusion (ACDF) or lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone.
- Conditions
- Spondylosis, Cervical Spondylosis, Spondylolisthesis, Herniated Nucleus Pulposus
- Trial name
- NCT03425682
- Testing
- ViBone
- Where
- 4 sites in United States
- Volunteers
- 118 people
- Sponsor
- Elutia Inc.
Back Pain, Chronic Low Back Pain
Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System
The purpose of this investigation is to establish the safety and efficacy of the Biostat System when used for treatment of chronic low back (lumbar) pain due to symptomatic internal disc disruptions (IDD) by comparing safety and…
- Conditions
- Back Pain, Chronic Low Back Pain, Internal Disc Disruption, Degenerative Disc Disease
- Trial name
- NCT01011816
- Testing
- BIOSTAT BIOLOGX, Saline
- Where
- 20 sites in United States
- Volunteers
- 220 people
- Sponsor
- Spinal Restoration, Inc.
Degenerative Disc Disease, Intervertebral Disc Disease
Treatment of Degenerative Disc Disease With Allogenic Mesenchymal Stem Cells (MSV)
In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells (MSC), obtained from bone marrow of healthy donors, for treatment of Degenerative Disc Disease (DDD).
- Conditions
- Degenerative Disc Disease, Intervertebral Disc Disease, Low Back Pain
- Trial name
- Disc_allo (NCT01860417)
- Testing
- Allogenic Mesenchymal Stromal Cells, Mepivacaine
- Where
- 2 sites in Spain
- Volunteers
- 24 people
- Sponsor
- Red de Terapia Celular
Lumbar Puncture
The First Puncture Success Rate of a Novel Injeq IQ-Tip™ System in Pediatric Lumbar Punctures
The investigation aims to demonstrate the first puncture success rate, as proxy of clinical benefit and clinical performance, of bioimpedance spectroscopy based spinal needle guidance method among pediatric hemato-oncology…
- Trial name
- IQ-LP-03 (NCT04070144)
- Testing
- IQ-Tip(tm) system
- Where
- 3 sites in Finland
- Volunteers
- 50 people
- Sponsor
- Injeq Ltd
Early Lumbar Disc Degeneration
A Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of Single Administration Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration
Study to show the safety, tolerability and preliminary effectiveness of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration
- Trial name
- NCT01182337
- Testing
- Intradiscal rhGDF-5, Vehicle control
- Where
- 7 sites in South Korea
- Volunteers
- 31 people
- Sponsor
- DePuy Spine
Lumbar Spinal Stenosis
MiDAS I (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
This is a multi-center, prospective, clinical study to assess the clinical application and outcomes of MILD® Interlaminar Decompression in patients with symptomatic lumbar spinal stenosis.
- Trial name
- MiDAS I (NCT00956631)
- Testing
- Interlaminar Decompression
- Where
- 13 sites in United States
- Volunteers
- 78 people
- Sponsor
- Vertos Medical, Inc.
Pain, Intractable, Pain, Chronic
Comparison of DTM™ SCS Therapy Combined With Conventional Medical Management (CMM) to CMM Alone in the Treatment of Intractable Back Pain Subjects Without Previous History of Lumbar Spine Surgery
The purpose of this investigational study is to document the safety, clinical effectiveness and health economic analytics of DTM™ SCS programming delivered through the Intellis™ neurostimulator in subjects with chronic…
- Trial name
- NCT06442410
- Testing
- DTM™ spinal cord stimulation therapy delivered via Intellis™ neurostimulator system, Conventional Medical Management (CMM)
- Where
- 12 sites in Belgium, Germany and 2 more
- Volunteers
- 115 people
- Sponsor
- MedtronicNeuro
Stenosis, Spondylosis
Efficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for posterolateral spine fusion with a retrospective comparison to a historical patient…
- Conditions
- Stenosis, Spondylosis, Degenerative Changes
- Trial name
- NCT01430299
- Testing
- Demineralized Bone Matrix, rh-BMP2
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- SeaSpine, Inc.
Degenerative Disc Disease
Retrospective Review of Integrity Implants FlareHawk® for Lumbar Fusion
This is a retrospective clinical study (chart review) of patients who have previously undergone Transforaminal Lumbar Interbody Fusion or Posterior Lumbar Interbody Fusion surgery with the FlareHawk expandable interbody fusion…
- Trial name
- NCT04057235
- Testing
- FlareHawk Interbody Fusion System
- Where
- 3 sites in United States
- Volunteers
- 129 people, healthy volunteers welcome
- Sponsor
- Integrity Implants Inc.
Central Nervous System Infections, Pseudotumor Cerebri
A Study to Test Performance of Needle Placements for Neuraxial Procedures Using Tactile Imaging vs Control
This study will compare the VerTouch device to the conventional palpation technique for performing diagnostic and therapeutic neuraxial procedures.
- Conditions
- Central Nervous System Infections, Pseudotumor Cerebri, Neurological Disorder, Cancer
- Trial name
- NCT04796935
- Testing
- Tactile Imaging (VerTouch), Control (palpation)
- Where
- 3 sites in United States
- Volunteers
- 95 people
- Sponsor
- IntuiTap Medical, Inc
Radiculopathy Lumbar
A Two-part Proof-of-Concept Study Assessing the Safety and Efficacy of LAT8881 in Lumbar Radicular Pain
The study consists of two parts. Part A will evaluate the safety and tolerability of intravenous LAT8881 in healthy volunteers using an ascending dose schedule.
- Trial name
- NCT05298306
- Testing
- LAT8881
- Where
- Australia
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Lateral Pharma Pty Ltd
Stenosis, Spondylosis
Efficacy and Safety of Integra Accell Evo3 DBM in Instrumented Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for instrumented lumbar spine fusion with a retrospective comparison to a historical patient…
- Conditions
- Stenosis, Spondylosis, Degenerative Changes
- Trial name
- NCT01714804
- Testing
- Accell Evo3 Prospective Use
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- SeaSpine, Inc.
Hunter Syndrome
Collection and Study of Cerebrospinal Fluid in Patients With Hunter Syndrome
The purpose of the study is to collect data on CSF biomarkers in patients with Hunter Syndrome that would serve as reference data for comparison with cognitively impaired patients with Hunter syndrome, patients with other…
- Trial name
- NCT01449240
- Testing
- No treatment
- Where
- 7 sites in United States, United Kingdom
- Volunteers
- 10 people
- Sponsor
- Shire
Low Back Pain
Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® Disc Augmentation System: A Pilot Study
The purpose of this study is to assess the safety of the Biostat Disc Augmentation System for the treatment of chronic low-back (lumbar) pain due to symptomatic internal disc disruptions (IDD) and to obtain preliminary efficacy…
- Trial name
- NCT00693784
- Testing
- Biostat® Disc Augmentation System
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Spinal Restoration, Inc.
Intervertebral Disc Degeneration
5-Year Global Study on MAST™ Minimally Invasive Fusion Procedures to Treat Degenerative Lumbar Spine (MASTERS-D2)
The purpose of this study is to evaluate the effectiveness of MAST techniques for anterior/lateral and posterior approaches in Degenerative Disc Disease (DDD) patients with spondylolisthesis (≥ grade I).
- Trial name
- MASTERS-D2 (NCT02617563)
- Testing
- Minimally invasive lumbar fusion
- Where
- 27 sites in Argentina, Austria and 15 more
- Volunteers
- 361 people
- Sponsor
- Medtronic Spinal and Biologics
Lumbar Degenerative Disc Disease
Lumbar Degenerative Disc Disease Treated With Anterior Tension Band System (ATB) With ALIF/FRA Spacer
Multi-center, prospective nonrandomized study of treatment for 1 and 2 level degenerative disc disease between L2 and S1. Patients will be followed for a minimum of 2 years.
- Trial name
- ATB (NCT01323387)
- Testing
- Interbody Fusion
- Volunteers
- 178 people, healthy volunteers welcome
- Sponsor
- Synthes USA HQ, Inc.
Lumbar Degenerative Disc Disease
Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery
Adjunct therapy for increasing posterolateral fusion success following single level posterior instrumented lumbar surgery.
- Trial name
- EXO-SPINE (NCT00744861)
- Testing
- Exospine, Exogen 4000+
- Volunteers
- 328 people
- Sponsor
- Bioventus LLC
Lumbar Surgery
Study of PEMF (Pulsed Electromagnetic Field) Therapy in the Treatment of Persistent Post-Operative Pain Following Lumbar Surgery
To demonstrate the analgesic effectiveness of 2 modalities of PEMF treatment compared to sham treatment in patients with persistent pain following lumbar surgery when treatment is administered twice daily over a 60 day period.
- Trial name
- NCT02416973
- Testing
- Provant
- Where
- 8 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Regenesis Biomedical, Inc.