Clinical trials: Device
Thromboembolic Events
Clinical Performance Evaluation of Pefakit® PiCT® UC In Vitro Diagnostic Medical Device
To demonstrate the substantial equivalence (SE) of Pefakit® PiCT® UC (test device, T) to aPTT-SP (Hemosil) (predicate device, P) in determining heparin levels in subjects undergoing heparin therapy in support of a United States…
- Trial name
- NCT02052544
- Where
- 3 sites in United States, Germany and 1 more
- Volunteers
- 123 people
- Sponsor
- dsm-firmenich Switzerland AG
Diabetes, Diabetes Mellitus, Type 1 Diabetes
Study on How Fiasp® Can Influence Blood Sugar Levels of type1 Diabetic Patients in Their Daily Lives, With the Help of the Freestyle Libre® Device
The purpose of this study is to collect information about Fiasp® to evaluate how effective Fiasp® is in treating elevated blood sugar in patients with type 1 diabetes, compared with the participant's previous insulin treatment.
- Trial name
- GoBolus (NCT03450863)
- Testing
- Fast-acting insulin aspart
- Where
- Germany
- Volunteers
- 320 people
- Sponsor
- Novo Nordisk A/S
Diagnostic and/or Interventional Radiology Procedures
Angio-Seal Interventional Radiology (IR) Registry
The purpose of this study is to collect data on the standard of care use of the St. Jude Medical (SJM) Angio Seal™ Evolution™ and V-Twist Integrated Platform (VIP) Devices in diagnostic and/or interventional radiology patient…
- Trial name
- NCT01222104
- Where
- 10 sites in United States
- Volunteers
- 634 people
- Sponsor
- Abbott Medical Devices
COVID-19, Asymptomatic COVID-19
A Clinical Evaluation of Proof Diagnostics Test System Including the Proof Diagnostics Reader and COVID-19 Test
To determine the accuracy of Proof Diagnostics COVID-19 Test in the intended, symptomatic and suspected/at-risk asymptomatic population and point-of-care use as compared to a standard molecular comparator, Quidel Lyra SARS-CoV-2…
- Trial name
- NCT05331976
- Testing
- Proof Lab Test System
- Where
- 3 sites in United States
- Volunteers
- 276 people
- Sponsor
- Proof Diagnostics
Cardiac Rhythm Disorder
EP Device Registry
This study will provide ongoing, high quality data on the safety, performance, and clinical benefits of Abbott's EP devices in a real-world setting.
- Trial name
- NCT04460209
- Testing
- Standard of Care
- Where
- 26 sites in Austria, Czechia and 8 more
- Volunteers
- 5,003 people
- Sponsor
- Abbott Medical Devices
Chronic Sinusitis
Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis
A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety and efficacy of balloon sinuplasty devices in pediatric patients with longstanding sinusitis following failed medical management.
- Trial name
- INTACT (NCT00939471)
- Testing
- Relieva™ Balloon Sinuplasty™ System
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Integra LifeSciences Corporation
Implantable Cardioverter Defibrillators, CRT-D Cardiac Resynchronization Therapy Defibrillator
LONGEVITY Study. Evaluation of the Device and Battery Longevity of Boston Scientific Market-released ICD and CRT-D Devices
The study is to determine the rate and cause of device replacements at 5 years post-implantation. It will assess the battery and device longevity of the Implantable Cardioverter Defibrillators (ICD) and CRT-D Cardiac…
- Trial name
- NCT02091011
- Where
- 80 sites in United States, Canada and 6 more
- Volunteers
- 1,600 people
- Sponsor
- Boston Scientific Corporation
Cerumen Impaction, Earwax Impaction
Performance, Safety and Participant Satisfaction Regarding A-CERUMEN® Medical Devices Used for the Removal of Earwax.
The ear canal - or external auditory meatus - is lined with skin that contains ceruminous glands. Cerumen - or earwax - is a combination of epithelial cells, dust, foreign bodies, as well as the secretions of the sebaceous glands…
- Conditions
- Cerumen Impaction, Earwax Impaction, Earwax Plug
- Trial name
- EAR (NCT07834593)
- Testing
- Unidose cerumenolytic solution, Spray cerumenolytic solution
- Where
- 3 sites in France
- Volunteers
- 80 people
- Sponsor
- Laboratoires Gilbert
Chondral or Osteochondral Lesion of Medial Femoral Condyle, Chondral or Osteochondral Lesion of Lateral Femoral Condyle
BiPhasic Cartilage Repair Implant (BiCRI) IDE Clinical Trial - Taiwan
The purpose of this trial is to evaluate the safety and effectiveness of the Biphasic Cartilage Repair Implant (BiCRI) compared to marrow stimulation in the treatment of chondral and osteochondral lesions located on the medial…
- Conditions
- Chondral or Osteochondral Lesion of Medial Femoral Condyle, Chondral or Osteochondral Lesion of Lateral Femoral Condyle, Chondral or Osteochondral Lesion of Trochlea
- Trial name
- NCT01477008
- Testing
- BiPhasic Cartilage Repair Implant, Marrow Stimulation
- Where
- 11 sites in Taiwan
- Volunteers
- 92 people
- Sponsor
- BioGend Therapeutics Co.Ltd
Cerebral Palsy (CP)
Evaluating the Bambini Teens Exoskeleton for Pediatric Cerebral Palsy
The goal of this clinical trial is to evaluate the safety and effectiveness of the Bambini Teens exoskeleton as a gait training tool in children aged 5 to 14 years diagnosed with cerebral palsy (CP).
- Trial name
- NCT07146932
- Testing
- Pediatric Lower Limb Exoskeleton (Bambini Teens)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- COSMO ROBOTICS CO., Ltd
Peripheral Intravenous Catheter Stabilization
A 7 Day Adhesive Device Wear Study to Evaluate BD StatLock™ Devices
This study is a prospective healthy human volunteer wear study to evaluate the safety and performance of the StatLock™ Catheter Stabilization Device and the StatLock™ stabilization device Accessory (Foam Strip) and to meet the…
- Trial name
- NCT04845906
- Testing
- StatLock™ Catheter Stabilization Device and the StatLock™ stabilization device accessory (Foam Strip)
- Where
- 2 sites in United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Becton, Dickinson and Company
Diabetes Mellitus
Lay-user Trial of the iGlucose Blood Glucose Monitoring System
Evaluation of the iGlucose Blood Glucose Monitoring System in the hands of lay users
- Trial name
- NCT02709707
- Testing
- Blood glucose monitor
- Where
- United States
- Volunteers
- 153 people, healthy volunteers welcome
- Sponsor
- Nina Peled
Brain Aneurysms
International Retrospective Study of Pipeline Embolization Device
The primary objective of this retrospective study is to determine the incidence of important safety outcomes in patients who have undergone Pipeline Embolization Device placement for intracranial aneurysms (IAs).
- Trial name
- IntrePED (NCT01558102)
- Where
- 17 sites in United States, Argentina and 4 more
- Volunteers
- 793 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
RDS of Prematurity, Surfactant Protein B Deficiency
Administration of Surfactant Through an Instillation Device Infasurf® (Calfactant) in Neonates- A Pilot Study
A pilot study to explore and determine feasibility and safety of the administration of surfactant through a new supraglottic device in patients from 500 to 5000 grams with RDS.
- Conditions
- RDS of Prematurity, Surfactant Protein B Deficiency, Chronic Lung Disease
- Trial name
- NCT04056741
- Testing
- surfactant airway device
- Where
- 4 sites in United States
- Volunteers
- 55 people
- Sponsor
- ONY
Allergy, Immunoglobulin E-Mediated Allergic Disorder
Kenota 1 CWS Method Comparison Validation Study
The goal of this Method Comparison Study is to compare total IgE results obtained from at least 360 subjects aged less than 80 years old using four different testing arms comprising three types of samples and two testing methods.
- Trial name
- NCT05702671
- Testing
- Total Immunoglobulin E, Obtained From Fingerstick Sample
- Where
- 3 sites in United States
- Volunteers
- 411 people, healthy volunteers welcome
- Sponsor
- Kenota Inc.
Hepatolenticular Degeneration; Wilson
Performance and Safety of MEX-CD1 Low-volume Continuous Veno-venous Haemodialysis Medical Device for Copper-extraction in Patients With Wilson's Disease
The goal of this clinical trial is to test the MEX-CD1 hemodialysis medical device in patients suffering from Wilson's Disease. The main questions it aims to answer are: Does the device work as expected by removing the excess of…
- Trial name
- MEXWILS (NCT05917327)
- Testing
- Low-volume continuous veno-venous haemodialysis
- Where
- 4 sites in France, Spain
- Volunteers
- 1 people
- Sponsor
- Mexbrain
Temperature Change, Body
Prizma Device Temperature Measurement
The purpose of the study is to evaluate the temperature measurements by the Prizma device.
- Trial name
- Prizma (NCT03340441)
- Testing
- Prizma
- Where
- Israel
- Volunteers
- 300 people
- Sponsor
- G Medical Innovations Ltd.
Hydrocephalus
Assessment of CSF Shunt Flow With Thermal Measurements A
This study evaluates the performance of a non-invasive thermal measurement device for assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt malfunction will be evaluated with the study device.
- Trial name
- NCT05015751
- Testing
- Thermal Anisotropy Measurement Device
- Where
- 4 sites in United States
- Volunteers
- 44 people
- Sponsor
- Rhaeos, Inc.
Aortic Valve Stenosis
CENTERA PMCF: Post-Market Follow-up of the CENTERA Transcatheter Heart Valve System
This study will monitor device performance and safety of the Edwards CENTERA Transcatheter Heart Valve (THV) system in patients with severe, symptomatic aortic valve stenosis who are indicated for aortic valve replacement.
- Trial name
- NCT03699345
- Testing
- Transcatheter Aortic Valve Replacement (TAVR)
- Where
- 11 sites in Denmark, France and 4 more
- Volunteers
- 87 people
- Sponsor
- Edwards Lifesciences
Vascular Access Device
A Clinical Registry to Demonstrate the Safety and Performance of Teleflex Vascular Access Devices
The objective of Teleflex's Vascular Access Device Registry (VADER) is to provide high-quality data on the performance, safety, and clinical benefits of Teleflex's vascular access devices when used in a real-world setting
- Trial name
- VADER (NCT06604039)
- Testing
- Central venous catheter
- Where
- 3 sites in United States
- Volunteers
- 2,500 people
- Sponsor
- Teleflex