Clinical trials: Clinical Performance
- Condition Clinical Performance
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
HIV Infections
Clinical Performance of Reveal G4 Rapid HIV-1 Antibody Test
To determine the efficacy of an improved rapid diagnostic test using venous whole blood and fingerstick whole blood. The clinical performance of Reveal G4 Rapid HIV-1 Antibody Test will be determined by comparing the results with…
- Trial name
- NCT02190578
- Testing
- Reveal G4
- Where
- 4 sites in United States
- Volunteers
- 1,649 people, healthy volunteers welcome
- Sponsor
- MedMira Laboratories Inc.
Elective HFOV for Respiratory Failure in Neonates/Infants, Rescue HFOV in Neonates and/Infants With Refractory Respiratory Failure Under Conventional Therapy
Servo-n HFOV Study: Safety and Performance in Neonates and Infants
The purpose of this study is to evaluate the safety and performance of High-Frequency Oscillatory Ventilation (HFOV) modes of the Servo-n ventilator in neonates and infants, by using a prospective, observational, single-arm…
- Trial name
- NCT06114992
- Testing
- Servo-n HFOV modes
- Where
- 4 sites in France, Poland and 1 more
- Volunteers
- 83 people
- Sponsor
- Maquet Critical Care AB
Diabetes Mellitus
Project BLOOM Regulatory Clinical Evaluation - System Accuracy, User Performance and System Use Evaluation
Clinical Evaluation including System Accuracy, User Performance, System Use, Instructions for Use and Marketing Claims Evaluation.
- Trial name
- NCT02767336
- Testing
- Blood Glucose Monitoring System.
- Where
- 4 sites in United Kingdom
- Volunteers
- 174 people
- Sponsor
- LifeScan
Hypertrophic Scars, Keloids
Scar Gel Product Family Clinical Investigation
The purpose of this PMCF investigation is to determine whether there are differences between the two formulations (Dermatix and Dermatix Ultra) in improving keloid and hypertrophic scars clinical symptoms and in the overall scar…
- Trial name
- NCT07684573
- Testing
- Dermatix, Dermatix Ultra
- Volunteers
- 150 people
- Sponsor
- Hanson Medical, Inc.
COVID-19
Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test
The purpose of this study is to evaluate the performance of the Bio-Self COVID-19 Antigen Home Test. The study will evaluate the accuracy (sensitivity and specificity) in a simulated home use environment when compared to a…
- Trial name
- NCT05334758
- Testing
- Bio-Self COVID-19 Antigen Home Test, Standard of Care COVID-19 Test, RT-PCR Test
- Where
- 3 sites in United States
- Volunteers
- 282 people, healthy volunteers welcome
- Sponsor
- BioTeke USA, LLC
Bloodstream Infection, Sepsis
Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast With Patient Blood Samples
The objective of the study is to determine the efficacy of the Microbio InfectID-BSI qPCR kit in a clinical laboratory environment using patient whole blood for pathogen detection and identification versus standard of care…
- Conditions
- Bloodstream Infection, Sepsis, Septic Shock
- Trial name
- IID-BSIqPCR (NCT06531031)
- Testing
- InfectID-BSI (Bloodstream Infection) qPCR Assay
- Where
- 8 sites in United States, Australia and 1 more
- Volunteers
- 1,500 people
- Sponsor
- Microbio Co Ltd
Mitral Valve or Aortic Valve Replacement
Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese Patients
Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese patients.
- Trial name
- NCT02523066
- Testing
- Magna Ease
- Where
- China
- Volunteers
- 215 people
- Sponsor
- Edwards Lifesciences
Myopia
Visual Performance of Highly Aspherical Lenslet Spectacles in Children (Ancillary to WS10246)
To evaluate the visual performance of (high and low contrast distance visual acuity, reading speed, near visual acuity, and near contrast sensitivity) of HAL spectacle lenses (habitual correction) in comparison with single vision…
- Trial name
- FIN-3102 (NCT07668102)
- Testing
- HAL spectacle lens, Single Vision spectacle lens
- Where
- 7 sites in United States
- Volunteers
- 88 people
- Sponsor
- Essilor International
Monitoring, ECG
Clinical Performance and Usability of the Heart Rate and Impedance Respiration Monitor Cable
This study aims to evaluate the performance and usability of a new physiological monitoring technology by collecting data from subjects across different age groups to support device development and clinical evaluation.
- Conditions
- Monitoring, ECG, Electrocardiogram
- Trial name
- NCT07893405
- Where
- Finland
- Volunteers
- 50 people
- Sponsor
- GE Healthcare
Coronary Artery Disease
Cynergy: the CYPHER-NEVO Registry
The purpose of this registry is to compare the safety and the performance of the NEVO™ Sirolimus-eluting Coronary Stent, once commercially available, to the CYPHER Select® Plus Sirolimus-eluting Coronary Stent in complex subjects…
- Trial name
- CYNERGY (NCT01106378)
- Where
- 3 sites in Brazil, South Korea and 1 more
- Volunteers
- 14,000 people
- Sponsor
- Cordis US Corp.
Bacterial Vaginosis, Candida Vaginitis
Performance Study of the Cobas® BV/CV Test on Samples From Participants With and Without Symptoms of Bacterial Vaginosis and Candida Vaginitis
In the clinical performance part of this study, prospectively acquired clinician-collected and clinician-instructed, self-collected vaginal swab specimens collected in cobas® PCR Media will be taken from a minimum of 500…
- Trial name
- NCT06975436
- Testing
- cobas® BV/CV test, BD Max™ Vaginal Panel, Cepheid Xpert Xpress MVP
- Where
- 10 sites in United States, Bulgaria and 1 more
- Volunteers
- 738 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Osteogenesis Imperfecta
Post-market Observational Study on JTIN Telescopic Nail in Osteogenesis Imperfecta Pediatric Patients
This study has been planned as part of the Orthofix Srl post-market active surveillance plan for the collection of data on both the clinical performance and the safety profile of the JTIN.
- Trial name
- JTIN (NCT05612139)
- Testing
- JTIN implantation surgery
- Where
- France
- Volunteers
- 14 people
- Sponsor
- Orthofix s.r.l.
Heart Defects, Congenital
Xeltis Pulmonary Valved Conduit Safety and Performance Study
This is a multi-center prospective, single-arm, non-randomized, open label study to assess safety and performance of the Xeltis Pulmonary Valved Conduit in subjects requiring Right Ventricular Outflow Tract correction or…
- Trial name
- NCT03405636
- Testing
- Xeltis Pulmonary Valved Conduit
- Where
- 4 sites in Hungary, Malaysia and 2 more
- Sponsor
- Xeltis
Bacteremia
Clinical Performance and Reproducibility of the Accelerate PhenoTest™ Blood Culture (BC) Kit With New Antibiotic Wave I Updates
This is a performance and reproducibility study to validate new or updated antimicrobials on the Accelerate PhenoTest™ BC kit. The data from this study will be used to support the submission to the FDA for clearance in the US and…
- Trial name
- NCT04295915
- Testing
- Specimens that meet inclusion criteria
- Where
- 3 sites in United States
- Volunteers
- 731 people, healthy volunteers welcome
- Sponsor
- Accelerate Diagnostics, Inc.
Hematology, Hematologic Test
Analytical and Clinical Performance Testing Plan
Clinical and analytical tests will be performed based on risk assessment and system specifications to verify that the performance of the investigational device is in accordance with its specifications.
- Trial name
- NCT03595501
- Testing
- Hematology Analyzer - OLO, Hematology Analyzer - Predicate
- Where
- United States
- Volunteers
- 679 people, healthy volunteers welcome
- Sponsor
- Sight Diagnostics
Temporomandibular Joint Disorders
Long-term Safety and Performance of Materialise's Patient-specific TMJ System.
This is a long-term (10 years), retrospective-prospective, observational, single-arm, monocenter study of patients to be treated with the Materialise TMJ Total Arthroplasty System for TMJ replacement.
- Trial name
- NCT06951178
- Testing
- TMJ Total Arthroplasty System (TMJ System)
- Where
- Denmark
- Volunteers
- 30 people
- Sponsor
- Materialise
Cardiothoracic Surgery
Clinical Study Evaluating the Performance of HEMOBLAST Bellows Compared to FLOSEAL Hemostatic Matrix in Cardiothoracic Operations
The purpose of this study is to evaluate the performance of HEMOBLAST™ compared to FLOSEAL in cardiothoracic operations.
- Trial name
- NCT03725098
- Testing
- HEMOBLAST Bellows, FLOSEAL
- Where
- 4 sites in United States
- Volunteers
- 105 people
- Sponsor
- Biom'Up France SAS
Intracranial Aneurysm, Brain Arterial Disease
Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform
BALT has designed an electronic platform to continue collecting clinical data as part of the post-marketing clinical follow-up of its devices.
- Conditions
- Intracranial Aneurysm, Brain Arterial Disease, Acute Ischemic Stroke, Peripheral Vascular Diseases
- Trial name
- EVIDENCE (NCT04927156)
- Testing
- BALT medical devices
- Where
- 12 sites in France, Germany and 1 more
- Volunteers
- 10,000 people
- Sponsor
- Balt Extrusion
Endodontically Treated Teeth
Long-term Performance and Safety of Biodentine™ in Patients Treated for Endodontic Indications
In this observational, retro-prospective, and multicenter PMCF clinical investigation, Biodentine™, an active dentine substitute for professional dental use only, is evaluated at 10 years post-treatment, in its endodontic…
- Trial name
- NCT05084742
- Testing
- Biodentine™
- Where
- 6 sites in France
- Volunteers
- 145 people
- Sponsor
- Septodont
Respiratory Disease
QIAstat-Dx® Respiratory Panel Plus (RPP) Clinical Performance Study
This study will evaluate the clinical performance of the QIAstat-Dx® Respiratory Panel Plus (RPP) SARS-CoV-2 target with a validated comparator method
- Trial name
- NCT05733559
- Testing
- QIAstat-Dx® Respiratory Panel Plus (RPP)
- Where
- United Kingdom
- Volunteers
- 565 people
- Sponsor
- QIAGEN Gaithersburg, Inc