Clinical trials: Validation Study
- Condition Validation Study
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
Hypertension
Withings Hypertension Notification Retrospective Study
This retrospective, non-interventional clinical investigation evaluates the diagnostic performance of the Withings Hypertension Notification Feature (HTNF), a software-only medical device (SaMD) that analyzes demographic…
- Trial name
- HTNF (NCT07631715)
- Testing
- Withings Blood Pressure Monitor (reference), Withings Hypertension Notification Feature (HTNF)
- Where
- France
- Volunteers
- 2,500 people, healthy volunteers welcome
- Sponsor
- Withings
Hypoxia
RDS MultiSense® SpO2 Validation Study
The purpose of this clinical study is to validate the oxygen saturation (SpO2) accuracy of the RDS MultiSense® Pulse Oximetry during non-motion conditions over the range of 70-100% arterial oxygen saturation (SaO2) as compared to…
- Trial name
- NCT05359328
- Testing
- Pulse Oximeter, Respiratory Rate, Heart Rate and Arterial line
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Rhythm Diagnostic Systems
Potassium Measurement
GAMMA Study: Patient Self-testing of Capillary Blood Potassium: A Validation Study and Measurement Performance in Patients.
Multicentre, open, prospective and interventional study investigating the CardioRenal device in capillary blood of patients.It will be conducted at multiple investigational sites.
- Trial name
- NCT05975632
- Testing
- Device: Self testing Potassium device
- Where
- 6 sites in France
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- CardioRenal
Pregnant Women
Sleep Position Pattern Recording
The main goal of this study is to validate the accuracy of the body position detection by non-invasive wearable monitors (Skiin garments, Myant Medical Corp) during sleep in pregnant participants.
- Trial name
- NCT06286904
- Testing
- Skiin Garment system
- Where
- Canada
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Myant Medical Corp.
Gaucher Disease
A Study Measuring Substances Potentially Indicating Bone Problems in Adults With Type 1 Gaucher Condition
Substances in the body, so-called biomarkers, can help predict the severity of Gaucher disease (GD)-related bone problems in adults.
- Trial name
- NCT05702814
- Testing
- No Intervention
- Where
- Spain
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Takeda
Respiratory Rate
Respiratory Rate Validation Study - ChroniSense Polso
20 volunteer test subjects entered into an accuracy study that is designed to validate accuracy of the respiratory rate of the ChroniSense Polso
- Trial name
- NCT05246358
- Testing
- ChoniSense Polso
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- ChroniSense Medical Ltd.
Osteoarthritis, Knee
A Study of the Construct Validity of Community Walking Speed Data Collected Remotely With the Canary canturioTM te Tibial Extension
The purpose of this study is to determine the construct validity of the Canary Tibial Extension's measure of self-selected community walking speed.
- Trial name
- NCT05539326
- Testing
- Performance Clinical Outcome Test
- Where
- 6 sites in United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Canary Medical
Growth Hormone Deficiency
Comparative Validation of the Growth Hormone Releasing Hormone and Arginine Test for the Diagnosis of Adult Growth Hormone Deficiency
The aim of the study is to determine the specificity and sensitivity of the combined growth hormone releasing hormone (GHRH) + Arginine test in healthy volunteers, subjects with highly probable adult growth hormone deficiency…
- Trial name
- NCT01060488
- Testing
- GHRH+Arg, GHRH+Arg, ITT, ITT, ITT, GHRH+Arg.
- Where
- France
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Male Infertility
A Novel Sperm Selection Method Provides Advantages Over Conventional Approaches
The goal of this clinical trial is to know if a novel sperm selection device (CA0) has a similar performance than the standard selection method in teratozoospermic and azoospermic men.
- Trial name
- NCT06545318
- Testing
- Density Gradient Centrifugation, CA0 chamber
- Where
- Mexico
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- Center of Innovation Technology & Reproductive Medicine
Subjects Presenting With Normal or With Ocular Pathology
Clinical Validation of New OCT System
To demonstrate clinical substantial equivalence of DRI OCT-1 as comparable to the commercially available Cirrus
- Trial name
- NCT01809704
- Where
- 3 sites in United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Topcon Medical Systems, Inc.
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.
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
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.
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.
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
Hypoxia
Polso SpO2 Accuracy Validation Study
The purpose of this study is to validate the oxygen saturation (SpO2) accuracy of the Polso Monitoring System during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by…
- Trial name
- NCT03735329
- Testing
- Diagnostic test of SPO2
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- ChroniSense Medical Ltd.
Hypoxia
Induced Hypoxia Study for Validation of SpO2 Accuracy
Validate Non-Motion SpO2 Accuracy from 70%-100% of various pulse oximeter/ sensor combinations and various OEM pulse oximeter modules and sensor combinations during induced hypoxia (desaturation).
- Trial name
- NCT00788983
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Nonin Medical, Inc