Clinical trials: Clinical Performance
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
Healthy Children
Clinical Performance and Antibacterial Effect of Alkasite Bioactive Material in Restoring Pulpotomized Primary Molars
The study aims to evaluate the clinical performance of Cention-Forte (CF) material in the restoration of pulpotomized second primary molars compared to conventional stainless steel crowns (SSC), and also to assess the…
- Trial name
- NCT07094854
- Testing
- Cention Forte alkasite bioactive restorative material, Stainless steel crown
- Where
- 2 sites in Egypt
- Volunteers
- 40 people
- Sponsor
- Noha Fouad
Burns, Pediatric Burns
Resistance, Plyometric, and Combined Exercise Training in Children With Severe Burns
Children who experience severe burns may continue to have reduced muscle strength, power, balance, and physical function after their wounds have healed.
- Conditions
- Burns, Pediatric Burns, Burn Injury
- Trial name
- NCT07843355
- Testing
- Traditional Resistance Training, Plyometric Training, Combined Resistance and Plyometric Training
- Where
- Egypt
- Volunteers
- 78 people
- Sponsor
- Qassim University
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
Dental Caries on Pit and Fissure Surface
Effectiveness of Fissure Sealants Bonded With Different Universal Adhesives
The purpose of this study is to evaluate and compare the clinical retention of a resin-based fissure sealant placed with prior application of etch-and-rinse and self-etch modes of universal adhesives.
- Trial name
- NCT02897089
- Testing
- Adhesive agent
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Hacettepe University
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
Single-Port Colorectal Surgeries
A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Colorectal Surgeries（SPiM-RWS-CR）
A real-world study to evaluate the clinical performance and safety of da Vinci SP Surgical System ("SP single-port robot" for short) for single-port robot-assisted colorectal surgeries in the real world, providing a real world…
- Trial name
- NCT06141421
- Testing
- procedure
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Ruijin Hospital
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
Prostate Cancer Diagnosis
PROVIZ - a Machine Learning Software, to Support Targeting of Prostate Biopsies on MR Images in Biopsy-naive Patients
To perform a traditional feasibility clinical investigation, as defined in ISO 14155:2020, to investigate preliminary feasibility, safety, and clinical performance information of a near-final design of the investigational…
- Trial name
- NCT06000046
- Testing
- Automatic image analysis
- Where
- Norway
- Volunteers
- 82 people
- Sponsor
- Norwegian University of Science and Technology
Dental Caries in Children
Evaluation of Glass Ionomer Cement Modified With Chlorhexidine and Titanium Dioxide in Primary Molars (RCT)
to investigate the effect of modifying GIC with different formulations on the antibacterial activity and clinical performance in reference to unmodified glass ionomer restorative materials.
- Trial name
- NCT05645029
- Testing
- glass ionomer-chlorhexidine, glass ionomer-titanium dioxide powder, glass ionomer
- Where
- Egypt
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Ain Shams University
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
Malocclusion, Narrow Maxilla
Clear Orthodontic Expander Versus Hyrax
This study will be conducted to evaluate the effectiveness of a clear expander fabricated from 2-mm biocompatible polyethylene terephthalate glycol (PETG) thermoforming material integrated with an expansion screw in achieving…
- Trial name
- COE-Hyarx (NCT07362160)
- Testing
- New clear expander, Hyrax expander
- Where
- Iraq
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Baghdad
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
Malaria
Performance Evaluation of Malaria Plus Rapid Diagnostic Tests (RDTs) for the Detection of Plasmodium Infections in Patients With Symptoms Suggestive of Malaria
This trial is part of a portfolio of studies designed to assess the clinical and operational performance of Abbott's NxTekTM Malaria Pf Plus and NxTekTM Malaria Pf/Pv Plus Rapid Test Devices.
- Trial name
- NCT05286359
- Testing
- NxTekTM Malaria Pf Plus Rapid Diagnostic Test Device
- Where
- Ethiopia
- Volunteers
- 1,023 people
- Sponsor
- Abbott Rapid Dx
Cardiopulmonary Bypass
Post-market Clinical Follow-up Study on the Performance and Safety of Coronary Artery Perfusion Cannula Used During Cardiopulmonary Bypass
Prior to the implementation of the Medical Device Regulation (MDR), clinical evaluation of older devices was carried out by Notified Bodies (MBs) based on clinical data obtained from equivalent devices, and CE certification was…
- Trial name
- NCT07620847
- Testing
- coronary artery perfusion cannula
- Volunteers
- 20 people
- Sponsor
- Bıçakcılar Tıbbi Cihazlar Sanayi ve Ticaret A.Ş.
Refractive Error, Glaucoma
A Post-market Clinical Study to Collect Safety and Performance Data on Johnson & Johnson Surgical Vision Products
Retrospective collection of data from medical records, multicenter, post-market clinical follow-up study.
- Conditions
- Refractive Error, Glaucoma, Cataracts, Clear Lens Exchange
- Trial name
- NCT05394324
- Testing
- Intervention
- Where
- 13 sites in United States, Germany and 1 more
- Volunteers
- 1,674 people
- Sponsor
- Johnson & Johnson Surgical Vision, Inc.
Ventilator Acquired Pneumonia, Catheter Related Blood Stream Infections
Ontario ICU Clinical Best Practices Demonstration Project
The pragmatic issue at hand how to get physicians and nurses to use best practices… and how to measure consequences of their implementation.
- Conditions
- Ventilator Acquired Pneumonia, Catheter Related Blood Stream Infections, Pressure Ulcer Prophylaxis, DVT Prophylaxis
- Trial name
- NCT00332982
- Testing
- Focused knowledge translation strategies
- Where
- Canada
- Sponsor
- Sunnybrook Health Sciences Centre
Deformity, Defect, Congenital
Observational Study on JuniOrtho Plating System for Deformities and Fractures Treatment in Lower Limb
Orthofix Srl put the JPS on the European market (2019) by the mean of a pre-market clinical evaluation made under the Medical Device Directive (MDD) requirements that were based on the analysis of the scientific literature of…
- Conditions
- Deformity, Defect, Congenital, Trauma
- Trial name
- JPS (NCT05245617)
- Testing
- JuniOrtho™ Plating System™
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Orthofix s.r.l.
Dental Caries
Clinical Performance of Bioactive Highly Filled Injectable Flowable Composite for Direct Posterior Occlusal Conservative Restorations Using FDI Criteria: Two Year Randomized Clinical Trial
The aim of this study is to evaluate Clinical Performance of bioactive highly filled injectable flowable composite for direct posterior occlusal conservative restorations using FDI Criteria
- Trial name
- NCT06790511
- Testing
- bioactive highly filled injectable flowable composite, highly filled injectable flowable composite
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Cairo University
Central Venous Catheter
Evaluation of Performance Over Dwell Time and Safety of the Central-venous Catheters Certofix® Paed
Central venous catheterisation is a medical technique that has become established over many decades and can be rated as State of the Art.
- Trial name
- NCT05124821
- Testing
- Central venous catheter intended to be used for children during routine clinical practice
- Where
- 3 sites in Germany, Italy
- Volunteers
- 100 people
- Sponsor
- B. Braun Melsungen AG