Clinical trials: Traumatic Disorder
Osteoarthritis, Post Traumatic Degenerative Disease
Post-Market Study of the EPIK Knee System
The purpose of this study is to determine the short-term (2 yr) and midterm (5 yr) cumulative revision rates of the EPIK™ Uni-compartmental Knee System.
- Trial name
- EPIK (NCT01464632)
- Testing
- EPIK™ uni-compartmental knee
- Where
- United States
- Sponsor
- Encore Medical, L.P.
Chronic Wounds, Venous Leg Ulcers (VLUs)
Efficacy of Carbonlife Amniotic Tissue Product in the Treatment of Chronic Wounds
Chronic wounds constitute a significant global health burden, affecting millions of individuals and contributing to increased morbidity, diminished quality of life, and rising healthcare costs.
- Conditions
- Chronic Wounds, Venous Leg Ulcers (VLUs), Diabetic Foot Ulcers (DFUs), Arterial Ulcers
- Trial name
- NCT07223892
- Testing
- Amniotic Tissue Allograft
- Volunteers
- 600 people
- Sponsor
- Bardia Anvar
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Ascension® Post- Approval Study; PyroCarbon Metacarpophalangeal Total Joint Prosthesis
This study is a non-randomized, consecutive enrollment, one-year post-approval study of patients who are treated with the Ascension® MCP.
- Conditions
- Rheumatoid Arthritis, Systemic Lupus Erythematosus, Osteoarthritis, Post-traumatic Arthritis
- Trial name
- MCP (NCT02408471)
- Testing
- Ascension® MCP Finger Implant
- Where
- 9 sites in United States
- Volunteers
- 97 people
- Sponsor
- Smith & Nephew, Inc.
Emotional Dysregulation, Therapeutic Alliance
Effectiveness of the SoundHeal Multi-Sensory Integrative Therapy Among Justice-Involved Youth
Emotional dysregulation in justice-involved youth (JIY) is a condition that significantly impacts young people, their families, and juvenile justice and public health systems.
- Conditions
- Emotional Dysregulation, Therapeutic Alliance, Depression Disorder, Anxiety Disorders
- Trial name
- HEAL-SLOJSC (NCT07364799)
- Testing
- Multi-sensory emotional regulation intervention (Heal)
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- SoundHeal
Epidermolysis Bullosa Dystrophica, Epidermolysis Bullosa Dystrophica, Recessive
A Natural History Study of Corneal Abrasions in Patients With Dystrophic Epidermolysis Bullosa (DEB)
This study is a non-interventional, observational study that will evaluate the natural history of corneal abrasions in patients with Dystrophic Epidermolysis Bullosa (DEB).
- Conditions
- Epidermolysis Bullosa Dystrophica, Epidermolysis Bullosa Dystrophica, Recessive, Epidermolysis Bullosa Dystrophica Dominans
- Trial name
- NCT06563414
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Krystal Biotech, Inc.
Post-Traumatic Stress Disorder, Stress Disorders, Post-Traumatic
Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder (PTSD)
This is a single-blind, placebo-controlled, parallel group study to evaluate the efficacy of BRL29060A (paroxetine hydrochloride hydrate, hereafter paroxetine) administered orally over the dose range of 20 mg to 50 mg once daily…
- Trial name
- NCT00557622
- Testing
- paroxetine
- Where
- 9 sites in Japan
- Volunteers
- 5 people
- Sponsor
- GlaxoSmithKline
Spinal Cord Injuries
Active Powered Prosthesis (APEX) for Spinal Cord Injury
The Active Powered Prosthesis (APEX) (AbiliTech Medical Inc., Minneapolis, MN) is a proof-of-concept shoulder-elbow-wrist device intended to provide non-invasive active powered robotic assistive movement to upper extremities.
- Trial name
- NCT03696927
- Testing
- Active Powered Prosthesis (APEX) for Spinal Cord Injury
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- AbiliTech Medical Inc.
Zygomaticomaxillary Complex Fracture, Zygomatic Fractures
BoneTape Feasibility Trial
This study aims to evaluate the safety, effectiveness, and usability of BoneTape, an innovative medical device designed to fix facial bone fractures, specifically in the zygomaticomaxillary (midface) region.
- Conditions
- Zygomaticomaxillary Complex Fracture, Zygomatic Fractures, Zygoma Fracture
- Trial name
- NCT06600854
- Testing
- BoneTape
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- Cohesys Inc.
Post-Traumatic Stress Disorder, PTSD
Software as a Medical Device for the Treatment of Patients With PTSD
To evaluate the efficacy and safety of Software as a Medical Device in patients with Post-Traumatic Stress Disorder (PTSD)
- Trial name
- NCT06589505
- Testing
- Software as a Medical Device
- Where
- 35 sites in Japan
- Volunteers
- 52 people
- Sponsor
- Otsuka Medical Devices Co., Ltd. Japan
Knee Osteoarthritis, Traumatic Arthritis of Knee
Post Market Clinical Follow-Up Study for EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur
MicroPort (MPO) is conducting this PMCF study to evaluate the safety and effectiveness of its EVOLUTION® BIOFOAM® Tibia and EVOLUTION® Cruciate Sacrificing/Cruciate Retaining (CS/CR) Porous Femur components, including EVOLUTION®…
- Conditions
- Knee Osteoarthritis, Traumatic Arthritis of Knee, Avascular Necrosis, Degenerative Joint Disease of Knee
- Trial name
- NCT04301622
- Testing
- Primary Knee implants
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- MicroPort Orthopedics Inc.
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
Non-inflammatory Degenerative Joint Disease
Evaluation of Post-Operative Recovery in ATTUNE® Total Knee Arthroplasty
This post-marketing investigation will evaluate the rate of recovery of the ATTUNE knee from the time of surgery through the 6 month endpoint in patients with severely painful and/or severely disabling Non-inflammatory…
- Trial name
- NCT02339610
- Testing
- ATTUNE Primary, Cemented Total Knee Replacement
- Where
- 4 sites in Netherlands
- Volunteers
- 200 people
- Sponsor
- DePuy Orthopaedics
Abdomenal Wound Trauma
Non-Comparative Study of Open Abdomen That Require the Use of Negative Pressure Wound Therapy (NPWT) for Temporary Abdominal Closure
A study in which subjects with a Grade 1 or Grade 2 open abdomen that require the use of NPWT for temporary abdominal closure. Subjects will use the NPWT system for up to 14 days, with a 21 day post study initiation follow-up…
- Trial name
- NCT03431220
- Testing
- RENASYS® TOUCH Negative Pressure Wound Therapy (NPWT) Device
- Where
- United States
- Sponsor
- Smith & Nephew, Inc.
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
Cochlear Hearing Loss, Cochlear Trauma
Using Electrocochleography During Cochlear Implantation of the Neuro Zti.
The main objective of this study is to evaluate the correspondence between eCochG and residual hearing by adding two modifications.
- Trial name
- PIC-22_eCoN (NCT04651660)
- Testing
- Neuro Cochlear Implant System
- Sponsor
- Oticon Medical
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
Carpal Tunnel Syndrome
Safety and Efficacy of a Device for the Relief of Pain Due to Carpal Tunnel Syndrome
Interventional study to evaluate efficacy and safety of an active splint.
- Trial name
- NCT03810326
- Testing
- CTR device (tradename named Xtend)
- Where
- Israel
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Yuinvent Innovations Ltd.
Laparotomy, Suture; Complications, Mechanical
DuraMesh Laparotomy Study
This is a multisite randomized control proof-of-concept trial to evaluate the safety of Duramesh laparotomy closure in the trauma and emergency laparotomy setting.
- Conditions
- Laparotomy, Suture; Complications, Mechanical, Hernia Incisional
- Trial name
- NCT03966768
- Testing
- Duramesh suturable mesh for laparotomy closure, Conventional suture for laparotomy closure
- Sponsor
- Mesh Suture Inc.