Clinical trials: Traumatic Wounds and Injuries
Concussion, Mild, Concussion; Eye
EYE-SYNC Concussion Classification Study
The purpose of this study is to determine the sensitivity and specificity of an aid in assessment of concussion based on eye-tracking, in comparison to a clinical reference standard appropriate for sport-related concussion…
- Conditions
- Concussion, Mild, Concussion; Eye, Concussion, Brain, Concussion, Severe
- Trial name
- NCT04381767
- Testing
- EYE-SYNC
- Where
- United States
- Volunteers
- 1,303 people
- Sponsor
- Sync-Think, Inc.
Chronic Subdural Hematomas
PHIL™ Middle Meningeal Artery Embolization for First-Line Treatment of Chronic Subdural Hematoma IDE Trial
This is a prospective, randomized, controlled, open-label, blinded endpoint (PROBE) clinical investigation in which patients with non-emergent chronic subdural hematoma (cSDH) requiring treatment will be randomized (1:1) to…
- Trial name
- PHILFIRST (NCT07576998)
- Testing
- PHIL™ (Precipitating Hydrophobic Injectable Liquid), Surgical evacuation
- Volunteers
- 475 people
- Sponsor
- Microvention-Terumo, Inc.
Traumatic Brain Injury
Fresh Intravenous Blood Samples for TBI Diagnostic Assay Development With Philips Point of Care System
The purpose of this study is to collect fresh whole blood within 12 hours from suspected mild head injury (Glasgow Coma Scale score 13-15) from subjects over the age of 18, to help verify that both UCH-L1 and GFAP can be detected…
- Trial name
- FIRST DOWN (NCT03060109)
- Testing
- Blood draw within 12 hours of injury
- Where
- 4 sites in Netherlands
- Volunteers
- 317 people
- Sponsor
- Banyan Biomarkers, Inc
Brain Injuries
Study of NNZ-2566 in Patients With Traumatic Brain Injury Under EFIC
The purpose of this study is to determine whether NNZ-2566 is safe and effective in the treatment of Traumatic Brain Injury (TBI).
- Trial name
- INTREPID2566 (NCT01366820)
- Testing
- NNZ-2566
- Where
- 6 sites in United States
- Volunteers
- 261 people
- Sponsor
- Neuren Pharmaceuticals Limited
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
Brain Concussion, Brain Injuries
An Evaluation of HS-1000 Device Capabilities in the Diagnosis and Assessment of Patients After Concussion
The HeadSense (HS) HS-1000 device, a new non-invasive brain monitor is expected to safely and accurately monitor concussed patients with minimal discomfort, potentially providing a new modality for concussion measurement.
- Trial name
- NCT02699346
- Testing
- HS-1000 recording
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- HeadSense Medical
Subdural Hematoma, Subdural Hematoma, Chronic
Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH) (HARMONY)
The aim of the study is to proof the effectiveness of Histoacryl® on preventing recurrence or progression of subdural hematoma after embolization of the middle meningeal artery.
- Trial name
- HARMONY (NCT07258069)
- Testing
- Histoacryl®
- Where
- 6 sites in Japan
- Volunteers
- 178 people
- Sponsor
- Aesculap AG
Degenerative Hip Joint Disease, Post-traumatic Osteoarthritis
Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty
The purpose of this post-market clinical follow up study is to assess the safety and effectiveness of the SYMBOL range of medical devices.
- Conditions
- Degenerative Hip Joint Disease, Post-traumatic Osteoarthritis, Hip Arthritis, Femoral Neck Fractures
- Trial name
- NCT05227924
- Testing
- Total hip arthroplasty (primary or revision)
- Where
- 9 sites in France
- Volunteers
- 747 people
- Sponsor
- Dedienne Sante S.A.S.
Acute Concussion Syndrome
Pilot Clinical Investigation Evaluating the Safety and Performance of RGn550 in Treating Sportspeople Suffering From Acute Concussion Syndrome
This is a controlled investigation, with randomization of the patients, which aims at evaluating the safety and performance of device RGn550 in treating sportspeople suffering from acute concussion syndrome.
- Trial name
- RECOVERY (NCT05647304)
- Testing
- RGn550 5 Hz-PWM, RGn550 10 Hz-PWM
- Where
- France
- Volunteers
- 50 people
- Sponsor
- REGEnLIFE SAS
Brain Injuries, Concussion, Mild
Evaluation and Validation of a Multimodal Brain Function Biomarker With NPC
This study is designed to collect data which will be used to associate changes in EEG, neurocognitive performance, eNPC and clinical symptoms in concussion subtypes.
- Conditions
- Brain Injuries, Concussion, Mild, Concussion, Brain, Near Point Convergence
- Trial name
- BSC-CI-NPC (NCT04074486)
- Testing
- BrainScope Ahead 300iP-O, SCAT5, Near Point Convergence
- Where
- 6 sites in United States
- Volunteers
- 1,318 people, healthy volunteers welcome
- Sponsor
- BrainScope Company, Inc.
Chronic Traumatic Encephalopathy
18F-AV-1451 and Florbetapir F 18 PET (Positron Emission Tomography) Imaging in Subjects at Risk for Chronic Traumatic Encephalopathy
This study will explore the use of flortaucipir as a biomarker for chronic traumatic encephalopathy (CTE) and examine the relationship between clinical presentation and tau deposition.
- Trial name
- NCT02079766
- Testing
- florbetapir F 18, Flortaucipir F18
- Where
- 2 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Avid Radiopharmaceuticals
Erectile Dysfunction, Spinal Cord Injury
Assess Efficacy in Subjects With Traumatic Spinal Cord Injury
Assess efficacy of Vardenafil in patients with traumatic spinal cord injury
- Trial name
- LEMDE (NCT00667966)
- Testing
- Vardenafil (Levitra, BAY 38-9456), 10 mg, Vardenafil (Levitra, BAY 38-9456), 20 mg
- Where
- 2 sites in Spain
- Volunteers
- 45 people
- Sponsor
- Bayer
Brain Injuries, Craniocerebral Trauma
Observational Study of the BrainScope® Ahead™ M-100 in UK Emergency Department Patients With Head Injury
The purpose of the current study is proposed to prospectively assess how accurately the BrainScope® Ahead™ M-100 can distinguish risk categories for acute head injury.
- Trial name
- NCT01430988
- Where
- 3 sites in United Kingdom
- Volunteers
- 318 people
- Sponsor
- BrainScope Company, Inc.
Brain Injuries, Craniocerebral Trauma
Assessment of Head Injury in the Emergency Department Using BrainScope® Ahead® Technology
The objectives of the study are to document device performance with respect to the primary and secondary endpoints.
- Trial name
- B-AHEAD II (NCT01556711)
- Where
- 11 sites in United States
- Volunteers
- 816 people
- Sponsor
- BrainScope Company, Inc.
Osteoarthritis, Avascular Necrosis
AL-2 MP-1 (Polyimide) Acetabular Liner
M.M.A.TECH Ltd. product is an Acetabular Liner Family produced of an advanced polyimide - MP-1™. M.M.A.TECH Ltd. produces the Liners according to EN ISO 13485:2012 approved manufacturing process and supplies them to the customer.
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Congenital Dysplasia of the Hip
- Trial name
- NCT02503891
- Testing
- MP-1 Polymer on Ceramic Articulation system
- Where
- Israel
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- M.M.A Tech Ltd.
Post-traumatic Stress Disorder, Persian Gulf Syndrome
Sentra AM® and Sentra PM® for Post-traumatic Stress Disorder (PTSD) and Gulf War Fibromyalgia (GWF)
An open-label clinical outcomes study to determine the safety and efficacy of Sentra AM® and Sentra PM® for post-traumatic stress disorder (PTSD) and Gulf War fibromyalgia (GWF).
- Trial name
- GWF001 (NCT01437891)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Stephanie Pavlik
Osteoarthritis, Hip, Rheumatoid Arthritis
Avenir Müller Hip Stem Post Market Surveillance Study
This study is a Post Market Clinical Follow up study to fulfil the post market surveillance obligations according to Medical Device Directive and European Medical Device Vigilance System (MEDDEV) 2.12-2.
- Conditions
- Osteoarthritis, Hip, Rheumatoid Arthritis, Fracture of Hip, Dislocated Hip
- Trial name
- NCT04079127
- Testing
- Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.
- Volunteers
- 150 people
- Sponsor
- Zimmer Biomet
Osteoarthritis, Rheumatoid Arthritis
A Clinical Investigation of the Copeland™ Humeral Resurfacing Head
The purpose of this study is to perform a five-year, prospective evaluation of the Copeland™ Humeral Resurfacing Head Prosthesis for outcome and durability.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Avascular Necrosis, Humeral Fractures
- Trial name
- NCT00698750
- Volunteers
- 34 people
- Sponsor
- Biomet Orthopedics, LLC
Brain Edema, TBI (Traumatic Brain Injury)
Dynamic Decompressive Craniotomy
Prospective observational study on patients undergoing decompressive craniotomy
- Conditions
- Brain Edema, TBI (Traumatic Brain Injury), Stroke, Acute, Cerebral Hemorrhage
- Trial name
- NCT05051488
- Testing
- Dynamic craniotomy
- Volunteers
- 20 people
- Sponsor
- Rohit Khanna, MD
Post-Concussion Syndrome
ATCell™ Expanded Autologous, Adipose-Derived Mesenchymal Stem Cells Deployed Via Intravenous Infusion
This is a Phase 1 Clinical Safety Study intended to provide preliminary assessments of the safety, tolerability, and clinical alleviation of symptoms associated with Post Concussion Syndrome (PCS), also known as Chronic…
- Trial name
- NCT04744051
- Testing
- 50 Adipose Derived Stem Cell Infusion, 150 Adipose Derived Stem Cell Infusion, 300 Adipose Derived Stem Cell Infusion
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- American CryoStem Corporation