Clinical trials: Performance
Non-Small Cell Lung Cancer, Colorectal Cancer
Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit
An interventional, prospective clinical performance study protocol, for the testing of DNA extracted from tumor tissue biopsy samples, using the therascreen® KRAS RGQ PCR Kit, from patients with Non-Small Cell Lung Cancer and…
- Trial name
- NCT05348187
- Testing
- therascreen® KRAS RGQ PCR Kit
- Where
- United Kingdom
- Volunteers
- 309 people
- Sponsor
- QIAGEN Gaithersburg, Inc
Localized T1-T2 Prostate Cancer
SpaceOAR System RWS in China
This study aims to evaluate the safety and performance of SpaceOAR System when it is used to create space between the rectum and prostate in men undergoing radiotherapy for localized T1-T2 prostate cancer in China via collecting…
- Trial name
- NCT05407714
- Testing
- SpaceOAR Treatment
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
Soil Transmitted Helminths, Schistosomiasis Mansoni
Evaluation of an AI-DP for STH Deworming Programs: a Study Protocol
The goal of this observational study is to test a new AI diagnostic tool for detection, specification and quantification of parasitic infections (Ascaris, Trichuris, hookworm and S.
- Trial name
- KAKADU (NCT06055530)
- Testing
- Artificial Intelligence Digital Pathology
- Volunteers
- 1,100 people, healthy volunteers welcome
- Sponsor
- Enaiblers AB
COVID-19
POC Study to Evaluate the Performance of the AcuVid COVID-19 Rapid Antigen Saliva Test
The AcuVid COVID-19 Rapid Antigen Saliva Test is a lateral flow immunoassay to detect SARS-CoV-2 nucleocapsid antigens in human saliva specimens from individuals suspected of COVID-19 by their healthcare provider within the first…
- Trial name
- NCT05119530
- Testing
- AcuVid COVID-19 Rapid Antigen Saliva Test
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Therma Bright Inc
Congenital Cytomegalovirus Infection
Assesment of Olfactory Disorders and Performance of a New Olfactory Test in Children With Congenital CMV
CMV lesions were found in the olfactory system of children with congenital CMV infection but no study has hitherto examined the impact of congenital CMV infection on olfaction.
- Trial name
- INFECSMELL (NCT02782988)
- Testing
- olfactory tests, otoacoustic emissions (OAE)
- Where
- 2 sites in France
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Hepatic Tumor
Multicenter Study to Evaluate a New Robotic Device for Image-guided Percutaneous Needle Placement
This study evaluates the safety and performance of a new robotic device in the treatment of hepatic thermoablation in adults. The new robotic device will be used in all patients.
- Trial name
- NCT04230642
- Testing
- The Quantum Surgical device
- Where
- 2 sites in France
- Volunteers
- 22 people
- Sponsor
- Quantum Surgical
Fractures, Bone, Impending Fracture
Retrospective Study on Clinical Performance and Safety Profile of Agile Nail
This study aims to retrospectively collect data from routine clinical practice in order to evaluate the safety profile of the Agile intramedullary nail, used in pediatric patients according to the manufacturer Instructions For…
- Conditions
- Fractures, Bone, Impending Fracture, Deformity; Bone
- Trial name
- Agile (NCT06412939)
- Testing
- Agile Nail
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Orthofix s.r.l.
Spinal Muscular Atrophy, Spine Deformity
Study of an Intrathecal Port and Catheter System for Subjects With Spinal Muscular Atrophy
The primary objective of the clinical investigation is to demonstrate successful clinical use of the ThecaFlex DRx™ System in delivering nusinersen in subjects with spinal muscular atrophy (SMA).
- Conditions
- Spinal Muscular Atrophy, Spine Deformity, Scoliosis
- Trial name
- PIERRE (NCT05866419)
- Testing
- ThecaFlex DRx System
- Where
- 21 sites in United States, Germany and 3 more
- Volunteers
- 90 people
- Sponsor
- Alcyone Therapeutics, Inc
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
Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma 3 Gene Methylation Combination Detection Kit (PCR Fluorescent Probe Method) Multicenter Clinical Trial
This clinical trial aims to systematically evaluate the clinical performance and accuracy of the HepaAiQ test kit, a multi-gene methylation assay based on PCR with fluorescent probe detection.
- Trial name
- NCT06842563
- Where
- China
- Volunteers
- 900 people
- Sponsor
- Singlera Genomics Inc.
Ocular Discharge
PMCF Study to Evaluate Performance and Safety of "LUXIDROPIN BABY & JUNIOR"
Children's tear film and ocular surface are increasingly exposed to environmental factors. The tear film is the most important barrier protecting the eye from external insults such as pollen, dust, sand.
- Trial name
- NCT05855486
- Testing
- Saline eye drops
- Where
- Italy
- Volunteers
- 32 people
- Sponsor
- C.O.C. Farmaceutici S.r.l.
Psoriasis
Patient Study to Evaluate the Safety and Emollient Performance of Doublebase Once in the Treatment of Psoriasis
This PMCF study is to obtain patient feedback using online questionnaires. There will be no involvement from healthcare professionals (HCPs) or investigator sites.
- Trial name
- NCT07817394
- Testing
- Doublebase Once
- Volunteers
- 100 people
- Sponsor
- Dermal Laboratories Ltd
Malaria Diagnosis, Malaria,Falciparum
Evaluation of the Performance of a hsRDT Versus cRDT in Reactive Case Detection of Malaria Infections
A systematic review assessing the role, appropriateness and benefits of the active case detection strategy, both proactive and reactive, in low malaria transmission settings.
- Trial name
- NCT03511443
- Testing
- hsRDT
- Where
- Burma
- Volunteers
- 1,980 people, healthy volunteers welcome
- Sponsor
- University Research Co, LLC
Veinous, Chemotherapy
A Retrospective, Observational, Multicenter Study to Evaluate the Safety and Performance of POLYSITE® and SEESITE® Implantable Ports
The purpose of this study is to evaluate performance and safety of POLYSITE® and SEESITE® implantable ports allowing repeated and prolonged access to the venous system for the administration of chemotherapy, antibiotics…
- Conditions
- Veinous, Chemotherapy, Antibiotics, Antiviral Drugs
- Trial name
- NCT05519761
- Testing
- Implantation of veinous access ports
- Where
- 3 sites in France
- Volunteers
- 250 people
- Sponsor
- Perouse Medical
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
Cataract Surgery
The PanOptix Trifocal IOL: A Study of Patient Satisfaction, Visual Disturbances, and Uncorrected Visual Performance
Prospective survey study of patients who previously underwent cataract surgery with the Alcon PanOptix or PanOptix Toric intraocular lens in both eyes.
- Trial name
- NCT04146961
- Testing
- Alcon PanOptix or PanOptix Toric IOL
- Where
- 3 sites in United States
- Volunteers
- 59 people
- Sponsor
- Research Insight LLC
Arrhythmia, Bradycardia
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival…
- Conditions
- Arrhythmia, Bradycardia, Heart Failure, Sinus Tachycardia
- Trial name
- PPR (NCT00271180)
- Testing
- Device
- Where
- 333 sites in United States, Australia and 33 more
- Volunteers
- 20,000 people
- Sponsor
- Medtronic
Healthy and Unhealthy Neonates
Performance Study of Nova StatStrip® Blood Glucose Monitoring Test System on Neonatal Capillary Blood
This study is to determine the validity of Nova StatStrip® blood glucose monitoring test system including the Nova StatStrip® glucose hospital meter and test strips in measuring Chinese neonatal capillary blood glucose levels by…
- Trial name
- NCT04194476
- Testing
- StatStrip blood glucose meter and strips
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Nova Biomedical
Motor Seizures
Study of Algorithm for Epilepsy Alert Device
An accelerometer with transmitting ability is worn on the wrist. Data of movements during seizures will be analyzed to upgrade algorithm that will identify seizures.
- Trial name
- NCT00497835
- Volunteers
- 15 people
- Sponsor
- Biolert
Covid19, Corona Virus Infection
A Follow On Community Testing Study To Evaluate The Performance of the Lucira COVID-19 All-In-One Test Kit
To evaluate the performance of the FDA EUA authorized Lucira COVID-19 All-In-One Test Kit for the qualitative detection of SARS-CoV-2 virus in nasal swab samples as compared to a known high sensitivity EUA RT-PCR among…
- Trial name
- NCT04720235
- Testing
- Lucira COVID-19 All-In-One test kit
- Where
- United States
- Volunteers
- 304 people, healthy volunteers welcome
- Sponsor
- Lucira Health Inc