Clinical trials: Validation Study
- Condition Validation Study
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
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.
Suicidality
A Study to Assess the Validation and Mapping of the Suicide Ideation and Behavior Assessment
The main purpose of this cross-sectional study is to generate data to support the psychometric properties of the Suicide Ideation and Behavior Assessment Tool (SIBAT) and validate its use in participants at imminent risk of…
- Trial name
- NCT03085108
- Testing
- No Intervention
- Where
- 4 sites in United States
- Volunteers
- 130 people
- Sponsor
- Janssen Scientific Affairs, LLC
Pathology
Instrument Precision Study for Validation of Philips Dx
The objective of this study is to evaluate precision of the Philips Dx system.
- Trial name
- NCT02699970
- Where
- United States
- Volunteers
- 399 people
- Sponsor
- Philips Digital & Computational Pathology
Autism Spectrum Disorder
Cognoa ASD Diagnosis Aid Validation Study
The primary objective of this study is to collect data to ascertain the Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of the current version of the Cognoa diagnostic device.
- Trial name
- NCT04151290
- Testing
- Cognoa ASD diagnostic device
- Where
- 16 sites in United States
- Volunteers
- 711 people
- Sponsor
- Cognoa, 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
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
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.
Clinical Indication for Brain MRI, Healthy Volunteers
Comparative Study of Conventional MR Images With Synthetically Reconstructed MR Images of the Brain
This study is being conducted for evaluation of 3D Synthetic MRI (SyMRI 15, 3D) for neuroimaging,
- Trial name
- NCT05425927
- Testing
- SyMRI 15 (3D)
- Where
- 6 sites in United States
- Volunteers
- 189 people, healthy volunteers welcome
- Sponsor
- SyntheticMR
Critical Illness
NIBP Validation Study
The purpose of this study is to compare measurements of blood pressure (BP) between the Philips non-invasive blood pressure (NIBP) system (including NIBP cuff and portable patient monitor) and invasive radial for Subject Group 2…
- Trial name
- NCT05673408
- Testing
- Philips IntelliVue X3 Patient Monitor
- Where
- 5 sites in United States
- Volunteers
- 189 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Covid19
Detection of COVID-19 Using Breath Analysis - Validation Study
DETECTION OF THE 2019 NOVEL CORONAVIRUS (SARS-CoV-2) USING BREATH ANALYSIS- VALIDATION STUDY
- Trial name
- COVID-19 (NCT04602949)
- Testing
- Breath Biopsy Analysis
- Where
- Israel
- Volunteers
- 2,558 people, healthy volunteers welcome
- Sponsor
- Scentech Medical Technologies Ltd
Urinary Incontinence, Stress
Quality of Life After Tension Free Transvaginal Sling / Tape Operation With a Titanized Surgical Tape (TiLOOP® Tape)
Validation of a new Quality of Life (QoL) questionnaire in a population of patient gaining a TiLOOP® TAPE surgical mesh for stabilization of the urethra.
- Trial name
- NCT01358214
- Testing
- Questionnaire on Quality of Life.
- Where
- Germany
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- pfm medical gmbh
COVID-19, Sars-CoV-2 Infection
This Trial is a Clinical Performance Validation Study That Will Evaluate the Clinical Agreement of the Sky Medical™ Rapid Antigen Test Comparing the Antigen Rapid Test to RT-PCR
Prospective study that will evaluate the clinical agreement of the Sky Medical™ Rapid Antigen Test compared to SARS-CoV-2 RT-PCR.
- Trial name
- NCT05491993
- Testing
- Sky Medical™ Rapid Antigen Test
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Sky Medical Supplies & Equipments, LLC
Quality of Life, Epilepsy (treatment Refractory)
Evaluation of the Epilepsy-related Quality of Life, Seizure-related Accidents and Validation of the Mjn-SERAS Solution in the Normalised Patient Environment with Real-World Data
The study will be prospective, multicentre, postmarketing clinical study, with a controlled and randomized design, to perform the analysis of 130 subjects with a clinical diagnosis of epilepsy, patients whose clinical semiology…
- Trial name
- SERAS_Home_RWD (NCT05845255)
- Testing
- mjn-SERAS
- Where
- 6 sites in Germany, Spain and 1 more
- Volunteers
- 130 people
- Sponsor
- MJN Neuroserveis, S.L
Endometriosis
Multicenter Study for Diagnostic Validation of a Laboratory Test for the Diagnosis of Endometriosis
Endometriosis affects at least 1 in 10 women worldwide and is associated with a diagnostic delay of 5-10 years. Currently, definitive diagnosis requires invasive laparoscopy, which is costly and burdensome for patients.
- Trial name
- NCT07553676
- Where
- 8 sites in Austria, Germany
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Diamens FlexCo
Epilepsy, Seizures
EpiCare@Home Validation Study for Focal Onset Seizures
The goal of this clinical trial is to validate a wearable seizure monitoring device, EpiCare@Home, as an objective seizure monitoring tool for people with focal onset epileptic seizures.
- Conditions
- Epilepsy, Seizures, Seizures, Focal, Seizure, Refractory
- Trial name
- NCT05738226
- Testing
- EpiCare@Home, wearable multimodal seizure monitoring system
- Where
- United States
- Sponsor
- Byteflies
Cognitive Intervention to Promote Healthy Development of Executive Function (EF) Skills in Young Children
Parent-Child EF Intervention
Koronis Biomedical Technologies Corporation (KBT) is developing a cognitive intervention to promote healthy development of Executive Function (EF) skills in young children by leveraging a smartphone-based training regime designed…
- Trial name
- NCT06924307
- Testing
- Executive Function Intervention
- Where
- 2 sites in United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Koronis Biomedical Technologies
Clostridium Difficile Infection
Validation of the GenePOC CDiff Assay for the Detection of the Toxin B Gene From Toxigenic Clostridium Difficile Strains
The primary purpose of this clinical investigation is to verify the performance of the GenePOC CDiff test on the GenePOC instrument.
- Trial name
- NCT02968758
- Testing
- Comparison between GenePOC PCR and Reference Method
- Where
- 7 sites in United States, Canada
- Volunteers
- 2,461 people
- Sponsor
- Meridian Bioscience, Inc.
Newborn Jaundice
BiliCam Clinical Validation Study
The goal of this study is to assess the accuracy of BiliCam, a non-invasive technology based on analysis of digital images obtained with an app installed on a commercial smartphone, in estimating total serum bilirubin levels in…
- Trial name
- NCT03246503
- Testing
- BiliCam estimated bilirubin (BCB)
- Where
- United States
- Volunteers
- 203 people, healthy volunteers welcome
- Sponsor
- BiliCam, LLC
Influenza A, Influenza B
Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B
The primary purpose of this study is to validate the sensitivity and specificity of the Respirio Flu Test in detecting Influenza A, when used by subjects, as compared to the gold standard for detection, Reverse Transcriptase…
- Trial name
- NCT02487173
- Testing
- Respirio Flu Test, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Sofia® Influenza A+B Fluorescent Immunoassay (FIA)
- Where
- 4 sites in Australia
- Volunteers
- 83 people
- Sponsor
- Ellume Pty Ltd