Clinical trials: Validation Studies
Atrial Fibrillation (AF), Atrial Fibrillation With Rapid Ventricular Response
Clinical Validation of SMD-RVECG for Predicting Atrial Fibrillation With Rapid Ventricular Response Within 2 Hours
The purpose of this retrospective study is to evaluate the clinical performance of SMD-RVECG, an artificial intelligence-based medical device software that analyzes single-lead electrocardiogram data to predict the risk of atrial…
- Trial name
- AFRVR (NCT07722039)
- Testing
- SMD-RVECG
- Volunteers
- 348 people
- Sponsor
- HUINNO Co., Ltd
Sleep Disordered Breathing (SDB), Sleep Apnea
Detection of Sleep Stages and Arousals Using Neural Network Classifiers
The objective of this clinical study is to evaluate the accuracy of the Smart Mask V1 System (herein 'Smart Mask') in measuring sleep stages-Stage N1/N2, Stage N3, Rapid Eye Movement (herein 'REM'), and WAKE-arousals, and the…
- Trial name
- SSAM (NCT07136272)
- Testing
- SSAM, Polysomnography, EnsoSleep
- Where
- 3 sites in United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Pathway Medtech, LLC.
Lung Cancer
OncoSweep Cancer Spotlight and Spectrum Product Line
CONQUER cancer study: To collect blood samples from cancer and non-cancer participants for development and validation of the 'OncoSweep Cancer Spotlight and Spectrum Product Line'
- Trial name
- NCT06261294
- Testing
- OncoSweep Lung Spotligh
- Where
- Taiwan
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- Pharus Taiwan, Inc.
Heart Failure, Kidney Disease
Neck-Worn Monitoring Sensor for - A Study for Monitoring Subjects With Fluid-Management Issues During Dialysis
The study has two objectives based on the intended-use measurements and populations described above. The first objective is to show that relative changes in impedance as measured by the test device (ΔSFI) are strongly correlated…
- Trial name
- NCT02140905
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- Baxter Healthcare Corporation
Diabetic Retinopathy, Diabetic Eye Problems
Validation Study of RETINA-AI Galaxy™, an Automated Diabetic Retinopathy Screening Device
Diabetes affects approximately 35 million Americans, each of whom needs at least one retinal exam per year. However, majority do not get their eye exam due to multiple prohibitive factors such as cost, transportation, difficulty…
- Conditions
- Diabetic Retinopathy, Diabetic Eye Problems, Diabetic Macular Edema
- Trial name
- NCT04774822
- Testing
- Color Fundus Photography, Mydriatics Agent, Optical Coherence Tomography (OCT)
- Where
- 3 sites in United States
- Volunteers
- 397 people
- Sponsor
- RETINA-AI Health, Inc.
Volunteers, Study Focus: Blood Pressure Measures
Valid-B.Well BP25 Study
Prospective, single-center, single-arm, open, comparative, validation of a commercialized device, repeated measures accuracy study designed in accordance with the requirements of the ISO 81060-2:2018 AAMI/ESH/ISO Universal…
- Trial name
- NCT07340957
- Testing
- Blood pressure measurement
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- B.Well Swiss AG
Acute Respiratory Infections (ARIs)
FebriDx® Pediatric Validation Study
The primary objective of this study is to determine performance characteristics of the FebriDx® test in differentiating bacterial from non-bacterial etiology among febrile pediatric patients (2-11 years) presenting to the…
- Trial name
- NCT07211997
- Testing
- FebriDx
- Where
- 10 sites in United States
- Volunteers
- 800 people
- Sponsor
- Lumos Diagnostics
Opioid-Related Disorders, Opiate Addiction
A Quantitative Study to Assess the Construct Validity of the Prescription Opioid Misuse and Abuse Questionnaire
The purposes of this study are to evaluate the validity and reproducibility of the POMAQ to identify opioid abuse and misuse behaviors among participants who have chronic pain which requires long-term opioid use.
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- POMAQ (NCT02678507)
- Testing
- Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)
- Volunteers
- 800 people
- Sponsor
- Member Companies of the Opioid PMR Consortium
Infection
Identigene STD Test Collection Kit Validation Study
The overall goal of the present study is to provide evidence of concordant test results using the Identigene STD Test Collection Kit for self-collection and transport of specimens to a qualified testing laboratory.
- Trial name
- NCT01471392
- Testing
- STD Diagnostic Kit (Identigene)
- Where
- United States
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Identigene
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.
Cardiovascular Diseases, Blood Pressure
VicorderCS NIBP Validation Study to Review The Ability to Capture Blood Pressure Measurements
80 Beats Medical introduces the VicorderCS, the next generation of our Vicorder technology designed to manage hypertension and cardiovascular risks.
- Conditions
- Cardiovascular Diseases, Blood Pressure, Hypertension
- Trial name
- NCT06560034
- Testing
- VicorderCS
- Where
- United States
- Volunteers
- 86 people
- Sponsor
- 80 Beats Medical
Coronary Artery Disease
Validation of a Vital Signs Monitoring Wristband
Today, continuous monitoring of vital signs remains a challenge since it generally requires the patient to be connected to multiple wired sensors, which restricts patient mobility in the intra-mural setting and complicates home…
- Trial name
- MULTI-VITAL (NCT05566886)
- Testing
- Continuous measurement of photoplethysmography at the wrist
- Where
- Netherlands
- Volunteers
- 100 people
- Sponsor
- Corsano Health B.V.
Preeclampsia (PE)
Validation of the MaiRa Preeclampsia Test for Screening Early/Late Preeclampsia in First and Second Trimesters
Preeclampsia (PE) is a major obstetric complication with severe short- and long-term consequences for both mother and fetus. Early detection is critical to mitigate PE-related morbidity and mortality.
- Trial name
- iPregnostic (NCT06716242)
- Testing
- Peripheral blood collection
- Where
- 11 sites in Spain
- Volunteers
- 7,473 people
- Sponsor
- iPremom
Validation Study
Gait Metric Validation of the Cionic Neural Sleeve
The purpose of this study is to determine the validity of the Neural Sleeve gait metrics compared to gait parameters assessed with a Protokinetics Zeno pressure sensitive walkway.
- Trial name
- NCT06503354
- Testing
- Neural Sleeve and Zeno walkway
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Cionic, Inc.
COVID-19, Severe Respiratory Distress Syndrome
suPAR Michigan M2C2 Heterogeneity Validation Cohort Study
This is a retrospective, non interventional cohort study using stored plasma samples from appoximately 300 adults hospitalized with confirmed COVID 19.
- Conditions
- COVID-19, Severe Respiratory Distress Syndrome, Acute Respiratory Distress Syndrome
- Trial name
- NCT07466524
- Testing
- suPARnostic® TurbiLatex Assay on Roche cobas c501
- Where
- United States
- Volunteers
- 367 people
- Sponsor
- ViroGates A/S
Pulmonary Disease, Chronic Obstructive
Effects of a 9-months Treatment of SPIRIVA on Health Related Quality of Life in Patients With COPD
The purpose of this study is to investigate the effect of a 9-month treatment of tiotropium (SPIRIVA®) 18 mcg once daily on Health Related Quality of Life and lung function in patients with a Chronic Obstructive Pulmonary Disease.
- Trial name
- NCT00274053
- Testing
- tiotropium
- Where
- 27 sites in France
- Volunteers
- 555 people
- Sponsor
- Boehringer Ingelheim
Kidney Transplantation, Liver Transplantation
A Study to Compare the Finger Prick Whole Blood MITRA Assay Method With the Established Venepuncture Whole Blood Method for Quantitative Determination of Tacrolimus Blood Concentrations in Transplant Patients
The purpose of this study is to assess relationship between tacrolimus concentrations determined via whole blood MITRA assay method with those determined using the established and validated whole blood venepuncture method using…
- Trial name
- MITRA (NCT03465969)
- Testing
- tacrolimus
- Where
- 4 sites in France, United Kingdom
- Volunteers
- 80 people
- Sponsor
- Astellas Pharma Europe Ltd.
Transthyretin Cardiac Amyloidosis
Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis
CONCERTO is a retrospective, observational, multicentric and single-arm study to perform an external validation of the cloud-based and AI-powered electrocardiogram (ECG) analysis platform, named Willem™, to detect Transthyretin…
- Trial name
- CONCERTO (NCT06978660)
- Where
- 8 sites in United States, France and 3 more
- Volunteers
- 2,200 people
- Sponsor
- Idoven 1903 S.L.
Alzheimer Disease, Dementia
Exploratory Clinical Study and Validation of Blood Biomarkers for Alzheimer's Disease
This is a 24-month, monocentric, exploratory and observational clinical study aimed at developing and validating a blood-based diagnostic test for Alzheimer's disease (AD).
- Conditions
- Alzheimer Disease, Dementia, Neurodegenerative Disorders, Cognitive Decline
- Trial name
- ADKIT (NCT07294586)
- Where
- France
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Amoneta Diagnostics SAS
Healthy, Febrile Illness
Prospective Study to Validate the Clinical Accuracy of Norbert Device to Measure Body Temperature
The study will evaluate the clinical bias and clinical repeatability of measuring body temperature using the Norbert Device (ND).
- Trial name
- NCT05640310
- Testing
- Norbert Device
- Volunteers
- healthy volunteers welcome
- Sponsor
- Norbert Health