Clinical trials: VALİDİTY
Atrial Fibrillation
Atrial Fibrillation Algorithms Clinical Validation Study
The purpose of the study is to evaluate the performances of investigational Irregular Rhythm Notification Feature (version 2.0) and Atrial Fibrillation History Feature algorithms.
- Trial name
- NCT04699812
- Testing
- ELECTROCARDIOGRAM (ECG) PATCH WEAR
- Where
- 4 sites in United States
- Volunteers
- 573 people, healthy volunteers welcome
- Sponsor
- Apple Inc.
Allergy, Allergic Asthma
Analytical Validation of the abioSCOPE Device With an IgE Test Panel: Point-of-Care Precision, Sample Type Comparison and Method Correlation
This is a multicenter, prospective, observational study to evaluate the analytical performance of the Abionic IgE Multi-Allergen Test Panel on the abioSCOPE® device in a U.S.
- Conditions
- Allergy, Allergic Asthma, Allergy to Cats, Allergy to House Dust
- Trial name
- NCT04401631
- Testing
- Blood Collection
- Where
- 3 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Abionic SA
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.
Healthy Adult, Sleep Apnea
Oura Ring OA15 Validation
The current study intends to collect data from Oura Ring time-locked to ground truth medical sleep diagnostic gold-standard polysomnography (PSG) for product research and development, investigational algorithm validation, and…
- Trial name
- NCT07908199
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Ouraring Inc.
Quantitative Validation for Ventricular SPECT Imaging
Validation of Quantitative Ventricular Function Imaging Single Photon Emission Tomography (Spect)Using the D-SPECT Cardiac Camera
The purpose of this study is to validate the use of DSPECT camera for the performance of quantitative spect ventricular function imaging by comparison to a validated procedure performed on standard nuclear cameras.
- Trial name
- NCT01296737
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Spectrum Dynamics
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
Gastro-esophageal Reflux Disease
Validation of a Non-invasive In-vitro Diagnostic Test (Peptest) Against Other Diagnostic Methods for GERD
The primary objective of this clinical study is to determine whether Peptest (Human Pepsin lateral flow in vitro diagnostic medical device) is equivalent to other GERD diagnostic methods commonly applied in clinical practice by…
- Trial name
- PEPTESTCN (NCT02456779)
- Testing
- in vitro diagnostic test (Peptest), Questionnaire
- Where
- 9 sites in China
- Volunteers
- 1,032 people, healthy volunteers welcome
- Sponsor
- MAAB (Shanghai) Medical Device Limited
Hypoxia
N600X Low Saturation Accuracy Validation
To compare pulse oximetry saturation measurements, during normal to low saturation, to saturation measurements made by a multi-wavelength CO-oximeter, taken from arterial blood samples from healthy human subjects.
- Trial name
- NCT05532670
- Testing
- Non-Invasive Controlled Hypoxia
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Pelvic Organ Prolapse
Validation of Transvaginal Tactile Imaging
The purpose of this study is to validate safety and effectiveness in assessment of the female pelvic floor tissue, and, assess the ability of Vaginal Tactile Imager (VTI) to detect early prolapse conditions and characterize the…
- Trial name
- VTI-03 (NCT01491334)
- Where
- 2 sites in United States
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- Artann Laboratories
Mental Health Services, Personality
Validation of Schema Scale of Mental Health Service
Digital Mental Health Service, MINDLiNG, has developed Schema Scale that identifies individual's personality based on schema theory. The goal of this study is to determine the reliability and validity of the Schema Scale.
- Trial name
- NCT05952063
- Testing
- Digital Psychological Test: Schema Scale
- Where
- South Korea
- Volunteers
- 234 people, healthy volunteers welcome
- Sponsor
- 40FY
Allergic Rhinitis, Rhinoconjunctivitis
Red Maple Trials Cat Allergen Natural Exposure Chamber Validation in Cat-allergic Subjects
To assess the reproducibility of the allergic response in the cat allergic subjects, measured as the change from baseline of the Total Nasal Symptom Score (TNSS) on the two challenge days.
- Conditions
- Allergic Rhinitis, Rhinoconjunctivitis, Exposure
- Trial name
- NEC (NCT03414801)
- Testing
- Allergen Exposure
- Where
- Canada
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Red Maple Trials Inc.
Healthy
Validation Study : FeetMe® Monitor Insoles for the Evaluation of Gait Speed
The aim of this study is to validate a smart insoles system in comparison to the gold-standard GaitRite in a healthy population.
- Trial name
- NCT04268017
- Testing
- FeetMe Monitor
- Where
- France
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- FeetMe
Sleep Apnea
A Validation Study of the NightOwl PAT-based Home Sleep Apnea Test
The objective of this study is to evaluate the performance of a miniaturized sleep apnea test, called NightOwl. The system consists of a sensor placed on the fingertip and a cloud-based analytics software.
- Trial name
- NCT04191668
- Testing
- NightOwl
- Where
- 3 sites in United States
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Ectosense NV
Psychological Well Being
Digital Self-Assessment of Well-Being: Validation of the Libellules Tool Against Gold-Standard Psychological Scales
The Libellules (WB6Dim) study aims to validate a digital self-assessment tool for measuring individual well-being across six dimensions: sleep and recovery, emotional climate, self-esteem, perceived autonomy, energy reservoir…
- Trial name
- NCT07301879
- Where
- France
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Clover Link
Infectious Disease, Tropical Disease
Collection of Human Biological Samples for the Development and Validation of New Methods of Diagnosis and for the Realization of Expertises Diagnostics in the Field of Infectious Diseases and Tropical
Direct constitution of collections from various samples taken on a prospective cohort of healthy volunteers, to prepare human biological samples of known characteristics (biochemical and serological in particular) and quality…
- Trial name
- Diagmicoll (NCT03912246)
- Testing
- biological samples, lumbar puncture
- Where
- 2 sites in France
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Genetic Health Risks
A Prospective, Monocentric Clinical Study for the Validation of in Vitro Diagnostic Tests Developed by Firalis
Firalis SA and its affiliate Amoneta Diagnostics SAS are developing novel in-vitro-diagnostic (IVD) tests for diverse diagnostic applications for major human diseases, including cardiovascular, and neurodegenerative disorders.
- Trial name
- ApoDiag (NCT06432192)
- Testing
- APO-Easy
- Where
- 2 sites in France
- Volunteers
- 1,474 people, healthy volunteers welcome
- Sponsor
- Firalis SA
Healthy
Validation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular Disease
Specificity measure of performance of the Irregular Heartbeat Detection algorithm (evaluated for the finger and wrist form factors) against the Masimo Radius VSM® reference ECG.
- Trial name
- NCT07223164
- Testing
- Masimo SET® and Masimo W1®
- Where
- United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Dementia, Mild Cognitive Impairment
HOme-based Brain Monitoring With a GARment-EEG to Study Cognitive Decline in the Aging Population
This study will investigate the validity of the HOGAR EEG/PSG monitoring kit designed by Bitbrain as a tool for characterizing and assessing cognitive function in older adults, as well as for detecting and predicting cognitive…
- Conditions
- Dementia, Mild Cognitive Impairment, Dementia Alzheimers, Dementia, Mixed
- Trial name
- Hogar (NCT06993207)
- Testing
- Home Lab
- Where
- Spain
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Bitbrain
Coronary Artery Disease
Comparison of Digital Electronic Stethoscope to Computed Tomography (CT) Angiography in Detection of Coronary Artery Disease
The study is designed to evaluate the predictive diagnostic accuracy of SonoMedica's CardioSond digital electronic stethoscope in the detection of coronary artery disease (CAD) in patients without known disease who are referred…
- Trial name
- NCT01040923
- Testing
- CardioSond Cardiac Sonospectrographic Analyzer
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- SonoMedica, Inc.
Obstructive Sleep Apnea
Validation and Usability Study of the SleepView+ Home Sleep Testing System for the Evaluation of Moderate to Severe Obstructive Sleep Apnea.
The goal of this observational study is to characterize the performance of the SleepView+ home sleep test system for the evaluation of moderate to severe obstructuve sleep apnea (OSA) in adult and pediatric patients (ages 12 and…
- Trial name
- NCT07476313
- Testing
- SleepView+
- Where
- 4 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Beacon Biosignals