Clinical trials: VALİDİTY
SARS-CoV-2 Infection, Influenza A
Usability and Clinical Validation of the Flu A/B/COVID-19 + RSV Multiplex Rapid Test
This will be a prospective study for the clinical validation of the CorDx Tyfast Flu A/B/COVID-19 + RSV Multiplex Rapid Test for the qualitative detection and differentiation of SARS-CoV-2, Influenza A, Influenza B and RSV in AN…
- Conditions
- SARS-CoV-2 Infection, Influenza A, Influenza B, RSV
- Trial name
- CorDx 4in1 (NCT07875270)
- Testing
- Flu A/B/COVID-19 + RSV Multiplex Rapid Test
- Where
- United States
- Volunteers
- 1,500 people
- Sponsor
- CorDx, Inc.
Asthma in Children, Bronchitis
Clinical Validation of Omron WheezeScan
The WheezeScan sensitivity and specificity are set to statistically prove equal to or higher values than the predicate PulmoTrack device model 2020.
- Conditions
- Asthma in Children, Bronchitis, Bronchiolitis
- Trial name
- NCT04144699
- Where
- 15 sites in United States
- Volunteers
- 240 people
- Sponsor
- Omron Healthcare Co., Ltd.
Respiratory Rate
ChroniSense Polso Wrist Worn Respiration Rate Validation Study
20 volunteer test subjects will be entered into an accuracy study that is designed to validate accuracy of the respiratory rate of the Polso Monitoring system
- Trial name
- NCT03750344
- Testing
- Diagnostic test
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- ChroniSense Medical Ltd.
Depressive Disorder, Major
Study to Evaluate the Performance Validity and Test-Retest Reliability of a Computer-Administered Cognitive Test Battery in Participants With Major Depressive Disorder (MDD)
The purpose of this study is to examine concurrent validity of 8 computerized tests intended for the assessment of cognitive function in participants with Major Depressive Disorder (MDD), relative to 8 corresponding and…
- Trial name
- NCT03014544
- Testing
- Computer- administered test battery, Examiner- administered test battery
- Where
- 20 sites in United States
- Volunteers
- 585 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy, Atrial Fibrillation
Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057
The objective of this study is to validate the performance of the electrocardiogram (ECG) function of the Masimo INVSENSOR00057 against contemporaneous measurements
- Trial name
- NCT06071754
- Testing
- Masimo INVSENSOR00057
- Where
- 4 sites in United States
- Volunteers
- 365 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Helicobacter Infections
Endofaster Test for Helicobacter Pylori Detection in Patients on Proton Pump Inhibitor Therapy
H. pylori infection is the most important causative agent of gastritis, and subsequent atrophic gastritis. The endoscopic diagnosis of H. pylori infection relies on urease tests such as the Clo test.
- Trial name
- NCT02126722
- Testing
- Gastroscopy, EndoFaster test, Clo test
- Where
- United Kingdom
- Volunteers
- 150 people
- Sponsor
- Niso Biomed S.R.L.
Healthy Participants
Development and Validation of a Driving Simulator for Evaluating the Residual Effects of Drugs on Driving Performance - Sensitivity Analysis Using Zopiclone As a Positive Control
The purpose of this study is to confirm of assay sensitivity of Driving Simulator by positive control
- Trial name
- NCT04108351
- Testing
- Road-tracking test, Car-following test, Harsh-braking test
- Where
- 2 sites in Japan
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Taisho Pharmaceutical Co., Ltd.
Chromosome 13 Aneuploidy, Chromosome 18 Aneuploidy
Non-invasive Prenatal Diagnostic Validation Study
The primary purpose of this study is to collect maternal blood samples from pregnant women to develop a non-invasive prenatal diagnostic test based on fetal DNA isolated from maternal blood.
- Conditions
- Chromosome 13 Aneuploidy, Chromosome 18 Aneuploidy, Chromosome 21 Aneuploidy, Sex Chromosome Aberrations
- Trial name
- NIPD (NCT01574781)
- Testing
- Blood draw, Cheek swab/Saliva Sampling
- Where
- United States
- Volunteers
- 1,781 people, healthy volunteers welcome
- Sponsor
- Natera, Inc.
Cardiac Rhythm Disturbance
Hexoskin Medical System - ECG Performance Testing
The goal of this observational study is to validate the efficacy of the Hexoskin Medical System (HMS) for its intended use (i.e., manual assessment of cardiac rhythm disturbances) in non-critical adult participants who are…
- Trial name
- NCT05970328
- Testing
- Hexoskin Medical System
- Where
- 2 sites in Canada
- Volunteers
- 75 people
- Sponsor
- Carré Technologies Inc.
Infiltration of Peripheral IV Therapy
ivWatch Sensor: Device Validation for Infiltrated Tissues
A single arm trial consisting of 98 adult volunteers to assess the safety and efficacy of ivWatch sensors when observing infiltrated tissues at common sites for peripheral IV therapy.
- Trial name
- NCT04064229
- Testing
- ivWatch Model 400 with SmartTouch Sensor, ivWatch Model 400 with Fiber Optic Sensor
- Where
- United States
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- ivWatch, LLC
Healthy Volunteers
Spire Medical Health Tag Actigraphy and Sleep Validation in Adults
The purpose of this study is to collect data to validate the step- (actigraphy) and sleep-tracking performance of the Medical Health Tag device developed by Spire Health.
- Trial name
- NCT04102709
- Testing
- Health Tag
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Spire, Inc.
Respiratory Rate
Bora Band Respiration Rate Study
The purpose of this study is to conduct a Respiratory Rate accuracy validation comparing the BORA BAND™ Wristband Monitoring System to the Reference.
- Trial name
- NCT04064645
- Testing
- Measurement of respiratory rate with DUT and comparison with reference
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Biosency
Healthy
Clinical Validation for SpO2 Function of Masimo INVSENSOR00069
Assess the accuracy of INVSENSOR00069's peripheral oxygen saturation (SpO2) against contemporaneous measurement from arterial blood gas (ABG) analysis.
- Trial name
- NCT06120777
- Testing
- INVSENSOR00069
- Where
- United States
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Aortic Aneurysm
Validation of a Software and the Follow-up of Anteropoterior Migration of Stent
The treatment of aortic aneurysms is today based on different indicators (diameters, lengths, angles, volumes of the arteries) measured on CT scan images. Several indicators are time consuming and complicatated to measure.
- Trial name
- ASMOT (NCT05287828)
- Testing
- Surgeons CT scan analysis, PRAEVAorta CT scan analysis
- Where
- France
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Nurea
Diabetes, Diabetic Retinopathy
Validation Study of RETINA-AI Galaxy™ v2.0, an Automated Diabetic Retinopathy Screening Device
Diabetes affects over 37 million Americans and over 530 million people globally. Each diabetic patient needs at least one retinal exam per year starting immediately at the time of diagnosis if they have Type II diabetes (and…
- Conditions
- Diabetes, Diabetic Retinopathy, Diabetic Macular Edema, Diabetic Eye Problems
- Trial name
- NCT05368623
- Testing
- Color fundus photograph, Optical Coherence Tomography (OCT) of the retina, Mydriatic Agent
- Where
- 3 sites in United States
- Volunteers
- 1,100 people
- Sponsor
- RETINA-AI Health, Inc.
Colorectal Cancer (CRC)
Colon Cancer Liquid Biopsy Investigation of Methylation-based Biomarkers Evaluation Using Delta-HLD (CLIMBED)
CLIMBED (Colon cancer Liquid biopsy Investigation of Methylation-based Biomarkers Evaluation using Delta-HLD) is a non-randomized, observational, cross-sectional clinical validation study designed to assess the performance of…
- Trial name
- CLIMBED (NCT07168876)
- Where
- Argentina
- Volunteers
- 3,200 people, healthy volunteers welcome
- Sponsor
- Epiliquid Holding, Inc
Blood Pressure
Validation of the JADE wRAP™, a Novel Blood Pressure Measurement Device, Using the Same Arm Sequential Method
The JADE wRAP™, a wrist worn cuff to measure blood pressure and its supporting software platform is currently at the final alpha prototype stage of development and is not intended for sale.
- Trial name
- NCT03452280
- Where
- Canada
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Jade Healthcare Group Inc.
Healthy
Validation of the ProSomnus® RPMO2 Device
The purpose of the study is to: 1. Evaluate the SpO2 accuracy of the oximeter component of the ProSomnus RPMO2 Device during non-motion conditions over the range of 70-100% SaO2 by comparison to SaO2 values determined by arterial…
- Trial name
- NCT06267976
- Testing
- ProSomnus RPMO2
- Where
- Canada
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- ProSomnus Sleep Technologies
Neurological Disorders
Development and Validation of a Novel Functional Eye-Tracking Software Application for Neurological Disorders
This study aims to develop and validate a sensitive and non-invasive eye-tracking software application. This study will obtain participant responses to brief cognitive tests designed to evaluate several key functions known to be…
- Trial name
- NCT05212727
- Testing
- Eye-tracking
- Where
- Canada
- Volunteers
- 300 people
- Sponsor
- Innodem Neurosciences
Chlamydial Infections
Validation of Chlamydia Diagnostic Codes in TriNetX US EHR Data
This study is a pharmacoepidemiologic method study based on the secondary use of pre-existing data that examines whether TriNetX, a global health research network encompassing a worldwide electronic health record (EHR), database…
- Trial name
- NCT07094373
- Where
- United States
- Volunteers
- 4,878,935 people
- Sponsor
- Sanofi