Clinical trials: Disk Prolapse
Discopathy, Herniated Cervical Disc
Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C
Study design: International, prospective, multicentre, non-randomised, observational study according to § 23b MPG. Objectives: Observational study to confirm the safety and performance of the cervical disc prosthesis MOVE®-C.
- Conditions
- Discopathy, Herniated Cervical Disc, Stenoses, Spinal, Radiculopathy
- Trial name
- PMCF_MOVE®-C (NCT05035693)
- Testing
- MOVE®-C
- Where
- 7 sites in Austria, Germany
- Volunteers
- 170 people, healthy volunteers welcome
- Sponsor
- NGMedical GmbH
Lumbar Disc Prolapse With Radiculopathy
Safety Study of ARO Spinal System as an Adjunct to Lumbar Decompression
To evaluate the clinical safety and effectiveness of the ARO Spinal System and to assess preliminary cost/benefit analysis in patients undergoing decompression surgery for symptomatic lumbar disc herniations.
- Trial name
- NCT01970514
- Testing
- ARO Spinal System
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- ARO Medical
Disk, Herniated
Safety and Effectiveness Study of the AO-1000 Device to Treat Contained Herniated Discs
To evaluate the safety and effectiveness of the AO-1000 device to treat and relieve the pain of symptomatic subjects with contained herniated discs. This single-arm pilot study will be used as a go vs.
- Trial name
- NCT01339377
- Testing
- AO-1000
- Where
- 3 sites in Canada
- Volunteers
- 39 people
- Sponsor
- ActiveO Inc.
Lumbar Disc Herniation, Annular Tear of Lumbar Disc
Post-Marketing Clinical Follow-Up of a Spine Implant
Post-Marketing Clinical Follow-up of an Anular Closure System (Barricaid®) to Confirm Comparability of Outcome between Devices with Subcomponents from Two Different Suppliers
- Trial name
- PMCFU (NCT03180749)
- Testing
- Follow up per standard of care
- Where
- 6 sites in Germany, Switzerland
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Intrinsic Therapeutics
Lumbar Disc Herniation
Trial to Show Non-inferiority / Superiority of an Endoscopic Transforaminal Discectomy to Standard Microdiscectomy
This study compares an endoscopic transforaminal surgical technique for the treatment of a herniated disc to the standard microsurgical procedure. Clinical parameters as well as health economy will be assessed.
- Trial name
- TESCORT (NCT01622413)
- Testing
- joimax TESSYS, Microdiscectomy
- Where
- 3 sites in Austria, Germany
- Sponsor
- Joimax GmbH
Degenerative Disc Disease, Spinal Stenosis
Burst Biologics Spinal Fusion Registry
A multicenter patient registry was created with aim of documenting how spine and neurosurgeons are utilizing Burst Biologics products along with patient outcomes.
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylitis, Spondylolisthesis
- Trial name
- NCT03064802
- Testing
- BioBurst Fluid, Burst Allograft
- Where
- 4 sites in United States
- Volunteers
- 450 people
- Sponsor
- Burst Biologics
Chronic Low Back Pain (CLBP), Intervertebral Disc Displacement
Sustained Acoustic Medicine for Chronic Low Back Pain Secondary to Herniated Nucleus Pulposus or Other Conditions
ZetrOZ's Ultrasonic Diathermy device is intended for use as a portable and wearable medical device which, when applied to various areas of the body applies Low Intensity Therapeutic Ultrasound (LITUS) to deep tissues.
- Trial name
- NCT02609854
- Testing
- Sustained Acoustic Medicine (SAM)
- Where
- 3 sites in United States
- Volunteers
- 65 people
- Sponsor
- ZetrOZ, Inc.
Disc Herniation With Radiculopathy
A Randomized Trial Comparing SpineJet® Hydrodiscectomy to Open Lumbar Microdiscectomy for Treatment of Lumbar Radiculopathy Due to Disc Herniation
The purpose of this study is to compare a standard surgical procedure, open surgical microdiscectomy, used primarily to relieve leg pain and repair disc herniation to a newer surgical procedure, hydrodiscectomy with Spinejet®.
- Trial name
- NCT00384007
- Testing
- Hydrodiscectomy with Spinejet
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- Pinnacle Pain Medicine
Lumbar Disc Herniation
A Study to Evaluate Safety and Exploratory Efficacy of KTP-001 in Subjects With Lumbar Disc Herniation
The purpose of this study is to evaluate the safety and exploratory efficacy of KTP-001 in subjects with lumbar disc herniation.
- Trial name
- NCT01978912
- Testing
- KTP-001
- Where
- 10 sites in United States
- Volunteers
- 24 people
- Sponsor
- Teijin America, Inc.
Intervertebral Disc Displacement, Intervertebral Disc Degeneration
Safety and Efficacy With NOVOCART® Disc Plus (ADCT) for the Treatment of Degenerative Disc Disease in Lumbar Spine
NOVOCART® Disc plus is being investigated to explore its clinical applicability, safety and efficacy in the repair of a herniated disc with an indication for an elective sequestrectomy, and of the adjacent degenerated disc, if…
- Trial name
- NDisc (NCT01640457)
- Testing
- NOVOCART® Disc plus, NOVOCART® Disc basic
- Where
- 10 sites in Austria, Germany
- Volunteers
- 120 people
- Sponsor
- Tetec AG
Herniated Disk Lumbar
Evaluation of Plenum® Tissue Ortho to Prevent Epidural Fibrosis and Post-laminectomy Syndrome.
The goal of this clinical trial is to compare if adding a polydioxanone membrane prevents epidural fibrosis and, consequently, the rate of occurrence of the post-laminectomy syndrome in participants undergoing microdiscectomy for…
- Trial name
- NCT05776628
- Testing
- Plenum® Tissue ortho membrane (polydioxanone membrane)
- Where
- Brazil
- Volunteers
- 36 people
- Sponsor
- M3 Health
Intervertebral Disc Disease, Lumbar Disc Disease
A Study of SI-6603 in Patients With Lumbar Disc Herniation
The purpose of this study is to evaluate the safety and efficacy of SI-6603(Condoliase) in patients with lumbar disc herniation.
- Trial name
- NCT02421601
- Testing
- Condoliase
- Where
- 48 sites in United States, Germany and 2 more
- Volunteers
- 1,011 people
- Sponsor
- Seikagaku Corporation
Disk Herniated Lumbar
Safety and Performance of a Hernia Blocking System
Prospective, multi-center, single-arm clinical study to assess the performance of an Hernia Blocking System in preventing clinically symptomatic recurrent lumbar disc herniation.
- Trial name
- NCT04188236
- Testing
- Hernia Blocking System
- Where
- 6 sites in Spain
- Volunteers
- 30 people
- Sponsor
- NEOS Surgery
Cervical Degenerative Disc Disease, Cervical Radiculopathy
M6-C Post Approval Study (PAS)
The M6-C Post Approval Study is a long term follow-up study of subjects previously enrolled and treated in the M6-C Artificial Cervical Disc IDE Study.
- Conditions
- Cervical Degenerative Disc Disease, Cervical Radiculopathy, Cervical Spinal Cord Compression, Cervical Disc Herniation
- Trial name
- NCT04122248
- Testing
- standard radiographic imaging, cervical total disc replacement
- Where
- 21 sites in United States
- Volunteers
- 152 people
- Sponsor
- Spinal Kinetics
Radiculopathy, Herniated Disc
Regenexx™ PL-Disc Versus Steroid Epidurals for Lumbar Radiculopathy
The primary objective of this study is to compare the improvement in subject-reported clinical outcomes for Regenexx PL-Disc vs.
- Conditions
- Radiculopathy, Herniated Disc, Disc Degeneration
- Trial name
- NCT01850771
- Testing
- Regenexx PL-Disc, Steroid Epidural
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Regenexx, LLC
Lumbar Radiculopathy
Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain
This is a Phase I/II, double-blind, parallel-group, randomized, placebo-controlled multi-centre trial in 180 patients randomized 1:1:1 to receive the IMP (Dexamethasone acetate microspheres for extended-release injectable…
- Trial name
- SALIENT (NCT03952377)
- Testing
- SX600
- Where
- 10 sites in Australia
- Volunteers
- 56 people
- Sponsor
- SpineThera Australia PTY LTD
Lumbar Vertebra Hernia
Clinical Trial to Assess Safety of SI-6603 in Patients With Lumbar Disc Herniation
The purpose of this study is to evaluate the safety of SI-6603 in lumbar disc herniation patients.
- Trial name
- NCT01282606
- Testing
- SI-6603
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Seikagaku Corporation
Lumbar Disc Herniation
Barricaid EU Post Market Study for Primary Lumbar Disc Herniation
The purpose of this multi-center post marketing surveillance study is to monitor the safety and performance of the Barricaid® ARD when used to surgically reconstruct the anulus of the L1 - S1 spinal disc.
- Trial name
- NCT01534065
- Testing
- Barricaid
- Volunteers
- 45 people
- Sponsor
- Intrinsic Therapeutics
Chronic Low-back Pain, Herniated Disc
LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant
The study is a post-market surveillance study of the Lumbar Implant for Stiffness Augmentation (LISA), a medical device, which is used to treat low-back pain that accompanies degenerative lesions of grades II, III, and IV…
- Conditions
- Chronic Low-back Pain, Herniated Disc, Degenerative Disc Disease, Lumbar Canal Stenosis
- Trial name
- LISA-PMCF (NCT04631133)
- Testing
- Lumbar Implant for Stiffness Augmentation (LISA)
- Where
- 5 sites in Denmark, France and 1 more
- Volunteers
- 136 people
- Sponsor
- BACKBONE
Herniation, Disc
Clinical Study to Evaluate the Anti-adhesion Efficacy and Safety of MegaShield®-SP in Comparison With Guardix-SP Plus After Spine Surgery
This study is Interventional, Parallel, Double-blinded, Randomized study. Subjects aged 20 to 70 years who had a Lumbar discectomy or laminectomy, MegaShield-SP® and Guardix-SP Plus will be applied.
- Trial name
- NCT06369233
- Testing
- MegaShield®-SP, Guardix-SP Plus
- Where
- 4 sites in South Korea
- Volunteers
- 80 people
- Sponsor
- L&C Bio