Clinical trials: Trauma Injury
Acute Spinal Cord Injury (SCI), Spinal Cord Diseases
NG004 in Incomplete Spinal Cord Injury Patients
This is a randomized, double-blind, placebo controlled, multicenter trial of NG004 in patients with acute traumatic incomplete cervical SCI.
- Conditions
- Acute Spinal Cord Injury (SCI), Spinal Cord Diseases, Spinal Cord Injuries, Trauma Nervous System
- Trial name
- SPROUT-2 (NCT07840196)
- Testing
- NG004
- Where
- 10 sites in Germany, Switzerland
- Volunteers
- 120 people
- Sponsor
- NovaGo Therapeutics AG
Septic Shock, Acute Respiratory Distress Syndrome
CytOSorb TreatMent Of Critically Ill PatientS Registry
Registry intended to provide a data repository and reporting infrastructure for the surveillance of CytoSorb device use in real-world critical care settings, and to serve as an objective, comprehensive, and scientifically-based…
- Conditions
- Septic Shock, Acute Respiratory Distress Syndrome, Trauma, Rhabdomyolysis
- Trial name
- COSMOS (NCT05146336)
- Testing
- CytoSorb
- Where
- 28 sites in Austria, Germany and 4 more
- Volunteers
- 3,000 people
- Sponsor
- CytoSorbents, Inc
Hypofibrinogenemia, Hemorrhage
Cryo-FIRST: Effectiveness of INTERCEPT Fibrinogen Complex (IFC) for Trauma-Associated Hemorrhage
The objective of this multicenter, single-arm, observational study is to determine the feasibility and effectiveness of early administration of FDA-approved, pre-thawed Pathogen Reduced Cryoprecipitated Fibrinogen Complex…
- Conditions
- Hypofibrinogenemia, Hemorrhage, Trauma Associated Hemorrhage, Hemorrhagic Shock
- Trial name
- CRYO-FIRST (NCT07218185)
- Testing
- Pathogen Reduced Cryoprecipitated Fibrinogen Complex
- Where
- 4 sites in United States
- Volunteers
- 320 people
- Sponsor
- Cerus Corporation
Peripheral Arterial Hemorrhage, Trauma
Onyx™ Liquid Embolic IDE Clinical Study
The purpose of this study is to evaluate the safety and effectiveness of Onyx™ LES in the treatment of subjects with active arterial bleeding in the peripheral vasculature outside of the heart and brain.
- Conditions
- Peripheral Arterial Hemorrhage, Trauma, GI Bleed, Ulcer
- Trial name
- NCT06742801
- Testing
- Onyx™ Liquid Embolic System
- Where
- 20 sites in United States
- Volunteers
- 119 people
- Sponsor
- Medtronic Endovascular
Trauma Injury, Maxilla Fracture
Prospective Study to Evaluate the Performance and the Safety of Global D's Implants of Craniomaxillofacial Surgery (CMF) Ranges Indicated for Trauma Surgery
This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety of the Global D implants (ORTRAUTEK® and MINITEK/MICROTEK®) used for…
- Conditions
- Trauma Injury, Maxilla Fracture, Maxillofacial Trauma
- Trial name
- NCT05742932
- Testing
- Trauma surgery using Global D's implants.
- Where
- 2 sites in France
- Volunteers
- 99 people
- Sponsor
- Global D
Acute Spinal Cord Injury (SCI), Spinal Cord Diseases
NG004 in Spinal Cord Injury Patients
This is the FIH, multicenter, open-label, sequential, multiple ascending dose trial of NG004 in patients with acute incomplete cervical SCI.
- Conditions
- Acute Spinal Cord Injury (SCI), Spinal Cord Diseases, Central Nervous System Diseases, Nervous System Diseases
- Trial name
- SPROUT (NCT06817577)
- Testing
- NG004
- Where
- 6 sites in Germany, Switzerland
- Volunteers
- 20 people
- Sponsor
- NovaGo Therapeutics AG
Orthopedic Disorder, Trauma Injury
X-BS Ortho Bone Graft Study
Randomised investigation of the osteoconductive performance and safety of CE-marked FDBS bone graft (GraftR3®), with contextual reference to CE-marked IBS (MBCP® Putty), in the filling of orthopaedic bone defects.
- Conditions
- Orthopedic Disorder, Trauma Injury, Extremity Injury
- Trial name
- NCT06326827
- Testing
- FDBS (GraftR3®), IBS (MBCP® Putty)
- Volunteers
- 200 people
- Sponsor
- Advanced Medical Solutions Ltd.
Mild Traumatic Brain Injury, Intracranial Lesions
TES HT100 Clinical Validation for Brain Injury Screening in Patients With Mild Head Trauma or Neurological Symptoms
The goal of this clinical study is to evaluate how accurately and safely the TES HT100 device can identify intracranial abnormalities in adult emergency department patients with mild head trauma or neurological symptoms that are…
- Conditions
- Mild Traumatic Brain Injury, Intracranial Lesions, Neurological Symptoms Not Related to Head Trauma
- Trial name
- TESCO (NCT07490418)
- Testing
- Temnographic Brain Screening Examination
- Where
- 3 sites in Italy, Poland
- Volunteers
- 850 people
- Sponsor
- B&B srl
Neuro ICU, Sub Arachnoid Hemorrhage
Comparison of Ultrasound Cerebral Perfusion Imaging With Routine Perfusion CT
The primary goal of neurocritical care is to prevent secondary brain injury, which worsens neurological outcomes. Because clinical monitoring is often insufficient due to the patient's condition and medical treatments, multimodal…
- Conditions
- Neuro ICU, Sub Arachnoid Hemorrhage, Neurological Complication, Cerebral Ischemia
- Trial name
- SCULPT (NCT07324421)
- Testing
- Ultrasound contrast agent (Contrast-enhanced ultrasound)
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Resolve Stroke
Peripheral Artery Disease, Popliteal Aneurysm
Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry
Collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
- Conditions
- Peripheral Artery Disease, Popliteal Aneurysm, Hemodialysis Access, Visceral Artery Aneurysms
- Trial name
- NCT04907240
- Testing
- GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
- Where
- 26 sites in Belgium, France and 7 more
- Volunteers
- 614 people
- Sponsor
- W.L.Gore & Associates
Vascular Trauma, Arterial Injury
An Open-label Study to Assess the Safety and Efficacy of SYMVESS® as a Vascular Conduit in Adolescents With Extremity Arterial Injury.
The goal of this study is to assess the safety and efficacy of Symvess in sexually mature adolescents (17 years of age or younger) who require a vascular conduit to repair an extremity arterial injury when autologous vein graft…
- Conditions
- Vascular Trauma, Arterial Injury, Arterial Bleeding
- Trial name
- NCT07762313
- Testing
- Acellular Tissue Engineered Vessel (Symvess)
- Volunteers
- 10 people
- Sponsor
- Humacyte, Inc.
Vascular Injury, Arterial Injury
Multicenter Study to Evaluate the Safety and Efficacy of SYMVESS™ in a Real World Setting in Patients With Extremity Arterial Injury Requiring Urgent Repair
The goal of this post-marketing observational study is to further assess the long-term safety and efficacy of Symvess in a real-world setting in adult patients with extremity arterial injury.
- Conditions
- Vascular Injury, Arterial Injury, Trauma Injury
- Trial name
- NCT07762794
- Testing
- Acellular Tissue Engineered Vessel
- Volunteers
- 125 people
- Sponsor
- Humacyte, Inc.
Trauma, Vascular System Injury
Humacyte Acellular Tissue Engineered Vessel (ATEV) in Patients With Vascular Trauma
This study evaluates the use of the Acellular Tissue Engineered Vessel (ATEV) in adults with vascular trauma below the neck who are undergoing vascular reconstructive surgery.
- Trial name
- NCT03005418
- Testing
- Acellular Tissue Engineered Vessel (ATEV)
- Where
- 29 sites in United States, Israel
- Volunteers
- 72 people
- Sponsor
- Humacyte, Inc.
Traumatic Brain Injury
Autologous Adipose-Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury
The global objective of this study is to establish the safety and investigate the potential treatment effect of an intravenous infusion of HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) on brain structure…
- Trial name
- NCT05951777
- Testing
- Autologous HB-adMSCs, Normal Saline
- Where
- 2 sites in United States
- Volunteers
- 51 people
- Sponsor
- Hope Biosciences LLC
Aneurysm of Aorta, Thoracic, Dissection of Aorta, Thoracic
TBE Zone 0/1 PMS in Japan
The goal of this surveillance is to confirm the safety and efficacy of TBE under actual use in the Zone 0/1 lesion on post-marketing usage conditions.
- Conditions
- Aneurysm of Aorta, Thoracic, Dissection of Aorta, Thoracic, Trauma
- Trial name
- NCT07691931
- Testing
- Gore® TAG® Thoracic Aortic Branch Stent Graft System
- Volunteers
- 75 people
- Sponsor
- W.L.Gore & Associates
Degenerative Disease, Oncology
Comprehensive Segmental Revision System
Clinical Data evaluation to document the performance and clinical outcomes of the Comprehensive Segmental Revision System.
- Conditions
- Degenerative Disease, Oncology, Revision Surgery, Trauma
- Trial name
- NCT03270982
- Testing
- Comprehensive SRS Replacement
- Where
- 4 sites in Canada, Denmark and 1 more
- Volunteers
- 105 people
- Sponsor
- Zimmer Biomet
Symptomatic Neuroma, Amputation
Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends
This pilot study evaluates the tolerability and feasibility of the Axoguard Large-Diameter Nerve Cap (sizes 5-7 mm) for protecting and preserving terminated nerve endings after limb trauma or amputation when immediate attention…
- Conditions
- Symptomatic Neuroma, Amputation, Chronic Nerve Pain
- Trial name
- REPOSE-XL℠ (NCT04865679)
- Testing
- Axoguard Nerve Cap®
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Axogen Corporation
Aorto-iliac Occlusive Disease (AIOD), Visceral Artery Occlusive Disease (VAOD)
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Post-Market Clinical Follow-Up (PMCF) Observational Registry (RE-PROVE)
Collect real-world post-market clinical follow-up data on subjects treated with the Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)
- Conditions
- Aorto-iliac Occlusive Disease (AIOD), Visceral Artery Occlusive Disease (VAOD), Isolated Artery Aneurysms (IAA), Trauma or Iatrogenic Vessel Injury
- Trial name
- NCT07279649
- Testing
- Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)
- Where
- Germany
- Volunteers
- 240 people
- Sponsor
- W.L.Gore & Associates
Degenerative Disc Disease (DDD), Instabilities
PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use.
In accordance with the European Medical Device Regulation MDR 2017/745/EU, the legal manufacturers of medical devices are obliged to evaluate medical devices with regard to their clinical performance and safety.
- Conditions
- Degenerative Disc Disease (DDD), Instabilities, Trauma, Deformity
- Trial name
- NCT05489822
- Testing
- VERTICALE® Cervical System
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Silony Medical GmbH
Sensorineural Hearing Loss, Tinnitus
Regenerative Medicine and Stem Cell-Based Interventions for Inner Ear Trauma, Tinnitus, and Sensorineural Hearing Loss
The HEAR-RESTORE study is an exploratory clinical research program designed to evaluate new diagnostic and regenerative approaches for individuals experiencing inner ear injury, tinnitus, and temporary or permanent hearing loss.
- Conditions
- Sensorineural Hearing Loss, Tinnitus, Acoustic Trauma, Inner Ear Injury
- Trial name
- HEAR-RESTORE (NCT07472023)
- Testing
- Audiologic Monitoring, Investigational Regenerative Pharmacologic Therapy, Stem Cell Regenerative Therapy
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Truway Health, Inc.