Clinical trials: Validation Studies
Arrhythmias, Cardiac, Atrial Fibrillation
AIMIGo 12L ECG Synthesis Software Pivotal Study for Arrythmia Detection
The study is a prospective single-arm multicenter clinical trial. Adult patients will be consented and enrolled in an outpatient cardiology office or Arrhythmia Clinics.
- Conditions
- Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter, Bradycardia
- Trial name
- VALID-ECG (NCT06123130)
- Testing
- Vectorcardiography (VECG)
- Where
- 5 sites in United States
- Volunteers
- 198 people
- Sponsor
- HeartBeam, Inc.
Heart Failure, Congestive
A Method Validation Study for Evaluation of Novel Treatments Limiting Pulmonary Oedema in Cardiac Failure
Transient receptor potential vanilloid 4 (TRPV4) channel blockade may be promising in the treatment of pulmonary oedema and dyspnoea in heart failure (HF) and acute decompensated heart failure (ADHF) patients by re-establishing…
- Trial name
- NCT02135861
- Testing
- DCE-MRI scans, Gadobutrol
- Where
- United Kingdom
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Sleep Apnea
AirSense 10 AHI Validation Study
The AirSense 10 platform is able to detect respiratory events at night and report these data via telemonitoring. The accuracy of the AirSense 10 will be compared with scoring with polysomnography (PSG).
- Trial name
- NCT03043703
- Testing
- AirSense 10 AutoSet for Her
- Where
- 2 sites in Germany
- Sponsor
- ResMed
Male Infertility
Validation of New Devices Against Ambient Electromagnetic Radiation
Project Summary Cell phones have become indispensable devices in the investigator's daily life. These phones operate between 400 and 2000 MHz frequency bands and emit radiofrequency electromagnetic waves (EMW).
- Trial name
- NCT04541459
- Testing
- new device against ambient electromagnetic radiation
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Waveguard GmbH
Aortic Stenosis
Multicenter Study for the Validation of Willem AI: Aortic StenoSis Early Diagnosis With AI-electrocardiogram Study
AoS-SEDAI study is an observational, multicenter, retrospective and prospective clinical study. This study aims to assess Willem Artificial Intelligence (AI) ability to distinguish between aortic stenosis (AS) and non-AS patients…
- Trial name
- AoS-SEDAI (NCT07479992)
- Testing
- Willem AI ECG assessment
- Where
- 2 sites in Germany
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Idoven 1903 S.L.
Healthy Population, Chronic Disease
Verily Clinical Study Watch Analytical Validation Study
This study is designed to evaluate the performance of the Verily Clinical Study Watch for the quantification of participants' movement and pulse rate when the wearer is at rest.
- Trial name
- NCT05534477
- Testing
- Verily Clinical Study Watch, Vivalink ECG Patch, Modus StepWatch 4
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Verily Life Sciences LLC
Blood Pressure, Hypertension
Validation Study of CART BP as a Wearable Cuffless Blood Pressure Monitor
This study aims to evaluate the accuracy of the CART BP, a medically approved ring-type blood pressure monitor, in comparison to the traditional auscultatory method using a dual-head stethoscope.
- Conditions
- Blood Pressure, Hypertension, Blood Pressure, High, Blood Pressure, Low
- Trial name
- NCT06513975
- Testing
- CART BP, sphygmomanometer
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Sky Labs
Movement Disorders, Parkinson Disease
Personal KinetiGraph® Clinical Validation Study
The purpose of this study is to clinically validate new measures of the Personal KinetiGraph® (PKG®).
- Trial name
- NCT05251701
- Testing
- Personal KinetiGraph® (PKG®) System
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Global Kinetics Corporation
Hearing Loss, Sensorineural
Fitting Strategy Study
To be conducted with adult participants with mild-to-moderate hearing loss to validate the effectiveness of the Web App fitting strategy.
- Trial name
- NCT04972162
- Testing
- Web App Strategy Fitting, Standard-of-care Fitting
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- WSAUD A/S
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.
Coronary Artery Disease, Coronary Arteriosclerosis
Validation of an Intracycle CT Motion CORrection Algorithm for Diagnostic AccuracY
To demonstrate the incremental utility of SSF for individuals undergoing CCTA, with expected improvements in image quality and diagnostic accuracy.
- Trial name
- VICTORY (NCT01856504)
- Where
- 7 sites in United States, Argentina and 3 more
- Volunteers
- 218 people
- Sponsor
- MDDX LLC
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
Osteoarthritis of the Knee
Effect Of Meloxicam Versus Placebo In Mainland Chinese Patients With Osteoarthritis Of The Knee
This study is to validate the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) tool in mainland Chinese patients with osteoarthritis of the knee .
- Trial name
- NCT01430559
- Testing
- Meloxicam
- Where
- 25 sites in China
- Volunteers
- 408 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
Reproducibility of Results, Safety Issues
Non-Invasive Blood Test Cross-Validation Study
The study considers a cross-validation approach to determine the effectiveness of a non-invasive comprehensive metabolic panel (NICMP), relative to the venipuncture method.
- Trial name
- NCT03991637
- Testing
- Non-Invasive Comprehensive Metabolic Panel
- Where
- United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Joseph Allen Jr.
Colorectal Cancer
CORRECT Study of Minimal Residual Disease Detection in Colorectal Cancer
The CORRECT - MRD II study will prospectively enroll patients who have undergone complete surgical resection for stage II or III colorectal cancer.
- Trial name
- MRD (NCT05210283)
- Testing
- MRD
- Where
- 32 sites in United States, Canada
- Volunteers
- 1,017 people
- Sponsor
- Exact Sciences Corporation
Blood Pressure
WBPS A Prospective, Method Comparison, Proof of Concept Study
The study will evaluate the accuracy of BP measurements by a new algorithm to be embedded to the existing CE-marked WinPack device, compared to two reference devices (one oscillometric and one volume-clamp device), in healthy…
- Trial name
- WBPS (NCT02934386)
- Testing
- WinMedical WinPack device
- Where
- Switzerland
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
Alzheimer's Disease, Amnestic Mild Cognitive Impairment
[18F]MK-6240 Positron Emission Tomography (PET) Tracer First-in-Human Validation Study (MK-6240-001)
This 2-part, open-label study was designed to investigate the safety, tolerability, and efficacy of [18F]MK-6240, a Positron Emission Tomography (PET) imaging agent, for the quantification of neurofibrillary tangle (NFT)…
- Trial name
- NCT02562989
- Testing
- [18F]MK-6240, ~185 MBq, [18F]MK-6240, ~160 MBq
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
Avicena LVDP Validation Study in Healthy Volunteers
The purpose of this study is to document the utility of the Vivio System in quantifying LVDP in healthy volunteers.
- Trial name
- NCT05673174
- Testing
- Non-Invasive Estimation of Left Ventricular Diastolic Pressure
- Where
- United States
- Volunteers
- 321 people, healthy volunteers welcome
- Sponsor
- Ventric Health, LLC
Allergy, Allergic Asthma
abioSCOPE IgE Assay to Aid in the Diagnosis of Allergies
This is a multicenter, prospective, observational study designed to determine the clinical sensitivity and specificity of the Abionic IVD CAPSULE Allergic Asthma panel performed on Abionic's abioSCOPE device using K3-EDTA…
- Conditions
- Allergy, Allergic Asthma, Allergy to Cats, Allergy to House Dust
- Trial name
- NCT04442932
- Testing
- Blood Collection
- Where
- 5 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Abionic SA