Clinical trials: Validation Studies
Clinical Accuracy of Vital Sign Pressure Sensor
V-Sensors for Vitals: Assessment of the Accuracy of a Vital Sign Sensor Mounted on a Smartphone
This trial seeks to demonstrate clinical accuracy and safety of the integrated V-Sensor when used by the general, healthy adult population interested in measuring their vital signs outside of the clinical setting.
- Trial name
- NCT03321851
- Testing
- V-sensor device user
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Léman Micro Devices SA
Heart Failure
Withings HFRN Retrospective Study
This is a fully decentralized retrospective, non-interventional study evaluating the diagnostic performance of the Withings Heart Function Risk Notification (HFRN), a software-only medical device (SaMD)
- Trial name
- NCT07654491
- Testing
- Withings Heart Function Risk Notification (HFRN), Claims-based heart-failure adjudication (reference standard)
- Where
- France
- Volunteers
- 9,000 people, healthy volunteers welcome
- Sponsor
- Withings
Bladder Disease, Bladder Retention Volume
ECHO-012 Kosmos Bladder Clinical Validation Study
The goal of this clinical trial is to compare the Kosmos Automatic Bladder Volume to the manual annotated bladder volume in participants across gender (male and female), age (children ages 7-17 and adults 18-89), and BMI strata…
- Conditions
- Bladder Disease, Bladder Retention Volume, Bladder Dysfunction, Bladder Function
- Trial name
- NCT06792851
- Testing
- Kosmos Bladder Volume Algorithm
- Where
- United States
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- EchoNous Inc.
Sleep Apnea
Prodigy, a Level 2 Sleep Study Device, Validation Study
The Prodigy system, developed by Cerebra Medical Ltd, allows for the generation of the same information in the home that is currently only obtained in in-laboratory studies.
- Trial name
- NCT05115305
- Where
- 2 sites in United States, Canada
- Volunteers
- 84 people
- Sponsor
- Cerebra Medical
Colorectal Cancer (CRC)
Colon Cancer Liquid Biopsy Investigation of Methylation-based Biomarkers Evaluation Using Delta-HLD (CLIMBED)
CLIMBED (Colon cancer Liquid biopsy Investigation of Methylation-based Biomarkers Evaluation using Delta-HLD) is a non-randomized, observational, cross-sectional clinical validation study designed to assess the performance of…
- Trial name
- CLIMBED (NCT07168876)
- Where
- Argentina
- Volunteers
- 3,200 people, healthy volunteers welcome
- Sponsor
- Epiliquid Holding, Inc
Hypoxia
SpO2 Hypoxia Accuracy Validation Study
The primary objective of this study is to evaluate the % oxygen saturation by pulse oximetry accuracy of a combined pulse oximetry system which consists of a Nonin sensor ), an adaptor cable, and an oximetry system during…
- Trial name
- NCT03348189
- Testing
- Pulse Oximeter
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Nonin Medical, Inc
Healthy, Glaucoma
Clinical Validation Study of RTVue Features
To perform a clinical validation study of RTVue features in volunteers with various ocular pathology or no ocular pathology.
- Trial name
- NCT01370850
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Optovue
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
Healthy
Pre-Market Algorithm Validation Study
The study sponsor has developed a patented medical device called Seipher Wellness. This is a non-invasive medical device that assesses heart health based on established cardiac parameters; timing events of the cardiac cycle.
- Trial name
- NCT02200601
- Testing
- Seipher Wellness
- Where
- Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Heart Force Medical Inc.
Hepatic Cancer
Seravue Validation Study for Hepatocellular Carcinoma (HCC) Diagnosis
Currently, ultrasound with or without AFP is the standard of care when it comes to surveillance for HCC in high-risk populations.
- Trial name
- Seravue (NCT06994130)
- Testing
- Seravue
- Where
- United States
- Volunteers
- 1,392 people
- Sponsor
- ImCare Biotech
Asphyxia Neonatorum
Biomarkers And Neurological Outcome in Neonates 2
Follow-up of participants of BANON1 study at age of at least 2 years. BANON1 (ClinicalTrials.gov ID: NCT03357250): Validation of biomarkers based on 24 months neuro-developmental outcome data in a human population for their…
- Trial name
- BANON2 (NCT04714775)
- Where
- 13 sites in Germany, Turkey (Türkiye)
- Volunteers
- 500 people
- Sponsor
- InfanDx AG
Mild Cognitive Impairment
A Study of a Self-Administered Memory Screening Test With Automated Reporting (SAMSTAR) in Participants With Mild Cognitive Impairment
The purpose of this study is to evaluate the psychometric properties of a Self-administered Memory Screening Test with Automated Reporting (SAMSTAR) adapted from the Rey Auditory Verbal Learning Test (RAVLT) in normal control…
- Trial name
- NCT02419183
- Testing
- SAMSTAR, RAVLT
- Where
- 2 sites in United States
- Volunteers
- 153 people
- Sponsor
- Janssen Research & Development, LLC
Alzheimer Disease, MCI
Validation Study of a New Digital Diagnostic and Treatment Test Based on Interactive Video Games for Alzheimer's Disease
This study aims to validate a novel, non-invasive diagnostic and digital therapeutic approach for Alzheimer's Disease (AD), centered on an interactive video game called BGaze Therapy.
- Trial name
- EyeAD (NCT06963879)
- Testing
- Bgaze Therapy, Bgaze Attention Task
- Where
- Spain
- Volunteers
- 60 people
- Sponsor
- Braingaze
Hypoxia, Desaturation of Blood
SpO2 Accuracy Validation of the OxySoft Sensor Via Reference CO-Oximetry Motion Study
SpO2 (oxygen saturation) and pulse rate accuracy of pulse oximetry equipment, OxySoft Sensor/N-600x and OxySoft Sensor/N-395, continuous measure of arterial oxygen saturation during hypoxic state throughout motion and non-motion…
- Trial name
- NCT04559763
- Testing
- Non-Invasive Controlled Hypoxia, Introduction of Motion conditions: tapping or rubbing
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Opioid-Related Disorders, Opiate Addiction
A Qualitative Study to Assess the Content Validity of the Prescription Opioid Misuse and Abuse Questionnaire
The purpose of this study is to evaluate the patient usability and reliability of the POMAQ survey to evaluate opioid misuse and abuse among adults with chronic moderate to severe pain, including patients who are opioid abusers…
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- POMAQ (NCT02660606)
- Testing
- Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- Member Companies of the Opioid PMR Consortium
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.
Fluid Retention Tissue
Measuring Thoracic Impedance in Hemodialysis Patients With the u-Cor Monitoring System
The purpose of this study is to measure the fluid changes in the body using a device called the µ-Cor System, an investigational device.
- Trial name
- MaTcH (NCT03072732)
- Testing
- u-Cor System, ZOE Fluid Status Monitor
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Zoll Medical Corporation
Osteoporosis, Fracture
Develop and Validate Ultrasonic Device for Osteoporotic Fracture Risk Assessment
Study to demonstrate that the Bone UltraSonic Scanner (BUSS) can aid in detection of osteoporosis and predict prevalent osteoporotic fractures.
- Conditions
- Osteoporosis, Fracture, Aging
- Trial name
- BUSS03 (NCT01123421)
- Where
- United States
- Volunteers
- 113 people
- Sponsor
- Artann Laboratories
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
Diabetes, Diabetic Retinopathy
Validation Study of RETINA-AI Galaxy™ v2.0, an Automated Diabetic Retinopathy Screening Device
Diabetes affects over 37 million Americans and over 530 million people globally. Each diabetic patient needs at least one retinal exam per year starting immediately at the time of diagnosis if they have Type II diabetes (and…
- Conditions
- Diabetes, Diabetic Retinopathy, Diabetic Macular Edema, Diabetic Eye Problems
- Trial name
- NCT05368623
- Testing
- Color fundus photograph, Optical Coherence Tomography (OCT) of the retina, Mydriatic Agent
- Where
- 3 sites in United States
- Volunteers
- 1,100 people
- Sponsor
- RETINA-AI Health, Inc.