Clinical trials: Validation Study
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
Skin Diseases, Skin Condition
Pilot Study: AI Algorithm for Dermatology Referral Optimization
The goal of this observational prospective and analytical study is to validate that the device is a valid tool for improving the adequacy of referrals to dermatology.
- Trial name
- DAO_DERIVATION (NCT06228014)
- Where
- Spain
- Volunteers
- 200 people
- Sponsor
- AI Labs Group S.L
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
Bipolar Disorder, Major Depressive Disorder
Clinical Validation Study for EDIT-B Test: an Aid for Differential Diagnosis of Bipolar Disorder, Based on RNA Editing Blood Biomarkers
Differentiation between major depressive disorder (MDD) and bipolar disorder (BD) as soon as possible in the patient journey represents a major clinical issue.
- Trial name
- EDIT-B (NCT05603819)
- Testing
- EDIT-B
- Where
- 4 sites in Denmark, France and 1 more
- Volunteers
- 418 people
- Sponsor
- Alcediag
To Assess Cardiovascular Function
QuantaFlo HD Clinical Validation Study
The primary aim of this validation protocol is to assess cardiovascular function through transthoracic echocardiography ("Echo") measurements and the QuantaFlo HD test measuring blood flow at the finger during a forced expiration…
- Trial name
- NCT07219693
- Testing
- QuantaFlo HD
- Where
- United States
- Volunteers
- 600 people
- Sponsor
- Semler Scientific
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.
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
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.
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
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
Systemic Inflammatory Response Syndrome (SIRS), Sepsis
IMproved PREdiction of Severe Sepsis in the Emergency Department
The purposes of this study is to determine whether Heparin Binding Protein (HBP) can be used as a marker of severe sepsis (including septic shock) in patients presenting to the emergency department with suspected infection.
- Conditions
- Systemic Inflammatory Response Syndrome (SIRS), Sepsis, Severe Sepsis, Septic Shock
- Trial name
- IMPRESSED (NCT01392508)
- Where
- 5 sites in United States, Sweden
- Volunteers
- 759 people
- Sponsor
- Axis Shield Diagnostics Ltd
Cardiac Disease
MyoVista wavECG Clinical Validation Study Versus Low e' on Echocardiogram
Clinical validation study of the MyoVista wavECG.
- Trial name
- NCT04804969
- Testing
- MyoVista wavECG Test
- Where
- 5 sites in United States
- Volunteers
- 575 people
- Sponsor
- Heart Test Laboratories, Inc.
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
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.
Cardiovascular Diseases, Hypertension
Investigation and Validation of a Study Project on Digital Therapy Management of Patients With Arterial Hypertension
The purpose of this pilot study is to exploratively test the basic feasibility of a clinical trial for the controlled investigation of the efficacy and effectiveness of iATROS digital therapy management in the treatment of…
- Trial name
- eXPLORE (NCT05580068)
- Testing
- Hypertension therapy through iATROS medical device
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- iATROS GmbH
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
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.