Clinical trials: Safety and Performance
Bone Defects
Retrospective Collection of Safety and Performance Data
This is a retrospective post market clinical follow-up study to compile real world clinical data on safety and efficacy of the synthetic bone graft substitutes in a commercial clinical setting in long bone and extremity defects…
- Trial name
- NCT04644536
- Testing
- Bone graft substitute
- Where
- Portugal
- Volunteers
- 50 people
- Sponsor
- Bioceramed
Acquired Brain Injury (Including Stroke), Spinal Cord Injury
Clinical Investigation to Validate the Safety and Performance of Integrating Functional Electrical Stimulation Into the ABLE Exoskeleton
The primary objective of this study is to validate the safety and clinical performance of the ABLE Exoskeleton with integrated Functional Electrical Stimulation (ABLE FES) in individuals with neurological conditions that impair…
- Conditions
- Acquired Brain Injury (Including Stroke), Spinal Cord Injury, Multiple Sclerosis
- Trial name
- NCT07550699
- Testing
- ABLE Exoskeleton with Functional Electrical Stimulation (ABLE FES)
- Where
- Austria
- Volunteers
- 14 people
- Sponsor
- ABLE Human Motion S.L.
Musculoskeletal Disorders, Skeletal Disorder
Observational Prospective PMCF Study to Confirm Performance and Safety of Intelect® Devices in Real World
DJO UK Ltd (ENOVIS) is conducting this study to confirm the performance and safety of the Chattanooga Intelect® devices in real world use.
- Conditions
- Musculoskeletal Disorders, Skeletal Disorder, Muscle Disorder
- Trial name
- INTELECT (NCT06809283)
- Where
- 4 sites in France, Italy and 1 more
- Volunteers
- 144 people
- Sponsor
- DJO UK Ltd
Aortic Valve Insufficiency, Aortic Aneurysm
HAART Annuloplasty Device Valve Repair Registry
Multicenter US registry study to assess procedure success and long-term (10-year) performance of the HAART 200 and HAART 300 Aortic Annuloplasty Devices when used during aortic valve repair in a routine cardiovascular practice…
- Trial name
- NCT04035356
- Testing
- Aortic valve repair
- Where
- 5 sites in United States
- Volunteers
- 183 people
- Sponsor
- Biostable Science & Engineering
Neurosurgery
Post-market Clinical Follow-up Plan of StypCel™ Absorbable Hemostat
This study is a post-market clinical follow-up (PMCF) plan for the StypCel™ Absorbable Hemostat, a medical device used to control bleeding during neurosurgery. The study include 108 patients .
- Trial name
- PMCFStypcel (NCT07199439)
- Where
- Latvia
- Volunteers
- 108 people
- Sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.
Spinal Cord Injury
Exoskeleton Training at Home to Assist Participants With Spinal Cord Injuries to Perform Ambulatory Functions.
The goal of this clinical trial is to to confirm the safety and performance of the ABLE Daily to perform ambulatory functions in home and community settings for people with spinal cord injury.
- Trial name
- NCT07062575
- Testing
- ABLE Daily
- Where
- Netherlands
- Volunteers
- 10 people
- Sponsor
- ABLE Human Motion S.L.
Non-inflammatory Degenerative Joint Disease (NIDJD) of the Knee
Safety and Performance of the Journey™ II UNI Unicompartmental Knee System
This clinical study will evaluate the early to midterm safety and performance of the JOURNEY™ II UNI UKS in patients with non-inflammatory degenerative joint disease of the knee requiring lateral or medial knee compartment…
- Trial name
- JII-Uni (NCT03768128)
- Testing
- Journey™ II UNI Unicompartmental Knee System
- Where
- 6 sites in United States, Italy and 1 more
- Volunteers
- 154 people
- Sponsor
- Smith & Nephew, Inc.
Tinnitus
The Treatment of Tinnitus With Transcutaneous Non-invasive Vagus Nerve Stimulation
The t-VNS STv3 device is a non-invasive, transcutaneous neurostimulator for influencing the afferent branches of the nervus vagus around the human ear.
- Trial name
- NCT01176734
- Testing
- tVNS-Device
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- cerbomed GmbH
Coronary Artery Diseases
BIOFLOW-III VIP Russia Registry Orsiro Stent System
Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). Along with it, an explanatory (hypothesis-finding) problem will be investigated, whether the patient's body…
- Trial name
- NCT02247492
- Where
- 7 sites in Russia
- Volunteers
- 200 people
- Sponsor
- Biotronik Russia
Diabetic Macular Edema
Everads Injector in Suprachoroidal Administration of TA Suspension, for Treatment of Patients With DME
This is an open-label pilot device study. The aim of the study is to evaluate the safety and performance of Everads Injector following single injection of suspension approved for ocular use into the suprachoroidal space.
- Trial name
- NCT06314217
- Testing
- Everads Injector
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- Everads Therapy
Bloodstream Infection
Reduction of Pathogen Load From the Blood in Septic Patients With Suspected, Life-threatening Bloodstream Infection
Safety and Performance Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the reduction of pathogen load from the blood in septic patients with suspected, life-threatening bloodstream infection
- Trial name
- NCT04260789
- Testing
- Seraph 100,The Microbind Affinity Blood Filter
- Where
- 25 sites in Austria, Belgium and 7 more
- Volunteers
- 232 people, healthy volunteers welcome
- Sponsor
- ExThera Medical Europe BV
Chronic Kidney Diseases, Diabetes
KidneYou - Innovative Digital Therapy
The aim of the study is to assess the improvement of health in patients affected by CKD when they are exposed to non-pharmacological treatment strategies as nutritional program (NP), physical activity program (PA) and mindfulness…
- Conditions
- Chronic Kidney Diseases, Diabetes, Arterial Hypertension, Chronic Glomerulonephritis
- Trial name
- NCT05286632
- Testing
- KidneYou APP
- Where
- Italy
- Volunteers
- 210 people
- Sponsor
- Advice Pharma Group srl
NEC
Sensing Oxygen Saturations Using Abdominal NIRS With an Investigational Realtime Device (Songbird)
Preterm infants are highly vulnerable and may suffer from multiple life-threatening conditions that manifest low tissue oxygenation (StO2).
- Trial name
- (Songbird) (NCT05278247)
- Testing
- NIRS
- Volunteers
- 50 people
- Sponsor
- Carag AG
Healthy Subjects
JetTouch Injection System to Deliver Saline Into the Bladder Wall of Healthy Volunteers
This research study is being done to see how well the JetTouch Needle-Free Endoscopic Injection System is able to deliver a solution safely into the bladder wall.
- Trial name
- NCT01862601
- Testing
- JetTouch Needle-free injection system
- Where
- 2 sites in United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- American Medical Systems
Infrarenal Abdominal Aortic Aneurysms, Aortoiliac Aneurysms
HORIZON CE Pivotal Study to Treat Abdominal Aortic Aneurysm
Clinical Investigation Design A prospective, open-label, non-randomized, interventional clinical study, sponsored by Endospan Ltd. Patients will be followed-up for five years.
- Trial name
- NCT02087501
- Testing
- Horizon™ Abdominal Aortic Aneurysm Stent Graft System
- Where
- 7 sites in Italy, Netherlands and 2 more
- Volunteers
- 30 people
- Sponsor
- Endospan Ltd.
Bone Regeneration, Safety Issues
Evaluation of Performance, Safety and Benefit of the Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation
This investigation is a pre-market, prospective, multi-center, randomized, single blinded, parallel controlled clinical investigation performed in at least 5 clinical centers for confirmatory purposes of the use of WHA as…
- Trial name
- NCT06383377
- Testing
- Tooth extraction and bone graft procedure
- Where
- 5 sites in Belgium
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Wishbone SA
Aneurysm, Intracranial
An EFS Assessing the Electrolytic eCLIPs System for Treatment of Intracranial Aneurysms
The purpose of this study is to investigate the feasibility and initial clinical safety of eCLIPs device use for the treatment of wide-necked bifurcation aneurysms.
- Trial name
- NCT04886505
- Testing
- Electrolytic eCLIPs Bifurcation System
- Sponsor
- Evasc Medical Systems Corp.
Peripheral Arterial Disease
Safety and Efficacy of the QBX Peripheral Balloon Expandable Stent System in Peripheral Artery Disease (PAD)
This study aims to evaluate the safety and performance of the QBX stent system in the treatment of PAD by reporting of peri- and postoperative complications, including major adverse vascular events (MAVE), Vascular Access Site…
- Trial name
- QBX-RADAR (NCT05799131)
- Testing
- QBX (5F/6F) Peripheral Balloon Expandable Stent System
- Where
- 4 sites in Belgium
- Volunteers
- 100 people
- Sponsor
- QualiMed Innovative Medizinprodukte GmbH
Oncology
Safety and Performance of Vectorio® in Conventional Trans-Arterial Chemo-Embolization (cTACE): A Post-Market Clinical Follow-up
This study is conducted within the frame of the Post-Market Surveillance (PMS) activities, as described in the Post Market Clinical Follow-up (PMCF) plan of Vectorio®.
- Trial name
- NCT05316077
- Where
- 3 sites in Austria, France and 1 more
- Volunteers
- 50 people
- Sponsor
- Guerbet
Distal Radius Fracture, Distal Ulna Fracture
PMCF Study on the Safety, Performance and Clinical Benefits of the DVR Plating System
The study is a single-center, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the DVR Plates.
- Conditions
- Distal Radius Fracture, Distal Ulna Fracture, Osteotomy
- Trial name
- NCT04653051
- Where
- United Kingdom
- Volunteers
- 111 people
- Sponsor
- Zimmer Biomet
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