Clinical trials: Validation Studies
- Condition Validation Studies
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
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.
Sleep Apnea
A Validation Study of the NightOwl 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
- NCT04764734
- Testing
- NightOwl
- Where
- 4 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Ectosense NV
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
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
Measure Accuracy of Respiratory Rate
Respiratory Rate Validation Study
The purpose of this study is to conduct a Respiratory Rate accuracy validation on pediatrics population comparing the Gabi SmartCare Gabi Band to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex- Ohmeda)…
- Trial name
- NCT05856422
- Testing
- Respiratory rate measure based on PPG
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Gabi SmartCare
Intracranial Pressure
Validation of Non-Invasive Intracranial Pressure Estimation Using CPMX3 in the Periorbital Vein: A Feasibility Study in Pediatric Patients
Intracranial pressure (ICP) monitoring is indicated in a wide range of neurological diseases. The combination of a linear ultrasound array with an integrated pressure sensor into a single handheld probe (ICP Probe) enables the…
- Trial name
- VENUS-ICPxP (NCT07550361)
- Testing
- CPMX3 measurement
- Where
- United States
- Sponsor
- Compremium AG
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
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.
Pathologic Processes
Pivotal Study for Validation of Philips Dx (PDx)
The primary objective of this study is to show safety and effectiveness of the PDx for In Vitro Diagnostic (IVD) use as an aid to the pathologist to view, review and diagnose digital images of surgical pathology slides.
- Trial name
- NCT02529137
- Where
- 4 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Philips Digital & Computational Pathology
Gastric Cancer
Gastric Cancer Early Detection by Multi-dimensional Analysis of cfDNA
To facilitate the early gastric cancer diagnosis, an assay based on assessing large-scale methylation and fragmentation profiles of the plasma cell free (cfDNA) will be developed and validated.
- Trial name
- NCT05668910
- Testing
- whole genomic methylation and fragmentation profile analysis of cfDNA
- Where
- China
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- GeneCast Biotechnology Co., Ltd.
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
Burns, Burn Injury
Deepview HHF Training and Validation Study
The purpose of this Study is to help expand the use of the DeepView AI System so that it can assess burn injuries on the hands, head/face, and feet. To do this, the Study will collect new images of burns in these areas.
- Conditions
- Burns, Burn Injury, Diagnostic
- Trial name
- UK HHF (NCT07677657)
- Testing
- DeepView AI System
- Volunteers
- 280 people
- Sponsor
- SpectralMD
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
Pathological Processes
This Study is the Clinical Validation Study for Validation for the Digital Pathology System 'SGi 1.0 + EPW 1.0 + Compatible Clinical Displays'
The primary objective of this study is to show safety and effectiveness of the investigational device for In Vitro Diagnostic (IVD) use as an aid to the pathologist to view, review and diagnose digital images of surgical…
- Trial name
- NCT07881874
- Testing
- Digital pathology system
- Where
- 2 sites in United States
- Volunteers
- 470 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.
Hearing Loss
Littlears Auditory Questionnaire: Validation Study in CI Children
The LittlEARS Auditory Questionnaire is designed to assess the development of the auditory behavior in children during the first two (hearing) years.
- Trial name
- LittlEars (NCT00785707)
- Where
- 5 sites in United States
- Volunteers
- 31 people
- Sponsor
- Med-El Corporation
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.
Pathology
Feature Detection Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
The objective of this study is to evaluate the repeatability and reproducibility of detection of histological features using whole slide imaging
- Trial name
- NCT03992768
- Testing
- Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
- Where
- 3 sites in United States
- Volunteers
- 540 people
- Sponsor
- Hamamatsu Photonics K.K.
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
Dengue
Dengue - Sample Collection Study Pakistan
The objective of this study is to collect well-characterized serum and plasma specimens from confirmed dengue positive and dengue negative subjects to support dengue diagnostic products development.
- Trial name
- NCT07203183
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Abbott Rapid Dx