Clinical trials: Validation Studies
Severe Sepsis
Symphony IL-6 Cutoff Validation Study for Patients at Risk of Severe Sepsis
Symphony IL-6 is a device that quantitates human IL-6 by fluorescence enzyme immunoassay (FEIA) from whole-blood specimens. Use of Symphony IL- 6 removes the need for plasma separation before testing.
- Trial name
- NCT05048927
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Bluejay Diagnostics, Inc.
Lung Cancer
OncoSweep Cancer Spotlight and Spectrum Product Line
CONQUER cancer study: To collect blood samples from cancer and non-cancer participants for development and validation of the 'OncoSweep Cancer Spotlight and Spectrum Product Line'
- Trial name
- NCT06261294
- Testing
- OncoSweep Lung Spotligh
- Where
- Taiwan
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- Pharus Taiwan, Inc.
Cardiac Arrhythmia
Validation Study: Extended Wear Performance of the Zio Monitor - SHASTA II
This trial assesses the wear performance of the Zio monitor, a long-term continuous ambulatory patch ECG monitor, in a representative population by evaluating (1) the wear duration (up to 30 days) of the device, (2) the…
- Trial name
- NCT07205367
- Testing
- Zio Monitor
- Where
- 2 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- iRhythm Technologies, Inc.
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.
Alzheimer Disease, Mild Cognitive Impairment
Optina Diagnostics' Cerebral ß-Amyloid Status (CAS) Test
This observational, cross-sectional study is designed to validate a novel diagnostic test for the detection of phenotypic changes in the retina that correlate with likely PET amyloid status (negative or positive), to aid in the…
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Mild Dementia
- Trial name
- REPHRASE (NCT05107882)
- Where
- 7 sites in United States, Canada
- Volunteers
- 466 people, healthy volunteers welcome
- Sponsor
- Optina Diagnostics Inc.
Lower Respiratory Tract Infection, Acute Bronchitis
Evaluating a Host-response Based Diagnostic for Distinguishing Between Bacterial and Viral Etiology in Patients With Lower Respiratory Tract Infection (LRTI)
The purpose of this study is to validate the diagnostic accuracy of a novel host-response based diagnostic tool for differentiating between bacterial and viral etiologies in adult patients aged 18 years and older with clinical…
- Conditions
- Lower Respiratory Tract Infection, Acute Bronchitis, Pneumonia, Chronic Obstructive Pulmonary Disease (COPD)
- Trial name
- OBSERVER (NCT03011515)
- Where
- Israel
- Volunteers
- 583 people, healthy volunteers welcome
- Sponsor
- MeMed Diagnostics Ltd.
Pneumococcal Disease, Invasive, Pneumococcal Disease
Serum Collection Study for Assay Development
The study will collect serum from 12 participants vaccinated with Gamma-PN to assist with assay development and validation
- Trial name
- NCT07205289
- Testing
- Gamma-PN
- Where
- Australia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- GPN Vaccines
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
Hypertension
Lifelight Non-Invasive Blood Pressure and Heart Rate Validation Study
Lifelight is a novel, calibration-free, software-only medical device that contactlessly measures pulse rate and blood pressure by measuring remote photoplethysmography (rPPG) signals of a patient's face using a standard…
- Trial name
- NCT06535152
- Testing
- Lifelight, Manual sphygmomanometer
- Where
- United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Xim Limited
Coronary Artery Disease, Cardiovascular Diseases
A Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease The CAD-det Validation Study
The purpose of the study is to collect acoustic, ECG, and clinical data from consenting participants, so that AusculSciences can perform analysis on the sounds produced by the heart and determine the accuracy of the CAD-det…
- Conditions
- Coronary Artery Disease, Cardiovascular Diseases, Atherosclerosis, Coronary Occlusion
- Trial name
- NCT04562142
- Testing
- CAD-det
- Where
- 2 sites in Canada
- Volunteers
- 395 people
- Sponsor
- AusculSciences Canada Inc.
Endometriosis
Validation Study for Endometriosis PRO
Assess the psychometric properties of the Endometriosis Symptom Diary (ESD) and the Endometriosis Impact Scale (EIS) and provide evidence whether the PRO measures are reliable, valid and able to detect changes over time in…
- Trial name
- VALEPRO (NCT01643122)
- Testing
- No drug
- Where
- 21 sites in United States, Germany
- Volunteers
- 275 people
- Sponsor
- Bayer
Atrial Fibrillation, Hypertension
Validation Study of an Advanced Blood Pressure Monitor
The proposed clinical study aims to validate the effectiveness of the WPM04 blood pressure monitor developed by Withings as a diagnostic tool for cardiovascular disorders.
- Conditions
- Atrial Fibrillation, Hypertension, Valvular Heart Disease
- Trial name
- TALISMAN (NCT04030494)
- Testing
- BP measurement, AF detection, VHD detection
- Where
- France
- Volunteers
- 218 people
- Sponsor
- Withings
Breast Cancer
A Prospective Validation Study of a Rapid Point-of-Care Breath Test for Breast Cancer
This is a multicenter, blinded prospective study of 2,000 women undergoing mammography for breast -related symptoms or signs. Breath tests will be performed in order to demonstrate that the outcome of mammography results combined…
- Trial name
- NCT02888366
- Where
- 4 sites in United States
- Volunteers
- 500 people
- Sponsor
- Menssana Research, Inc.
Anticoagulation With Apixaban
Apixaban Validation Study - Additional Study on Fresh Samples
The objective is to demonstrate the performances of STA® - Apixaban Calibrator \& STA® - Apixaban Control used in combination with STA® - Liquid Anti-Xa to measure apixaban concentration in plasma.
- Trial name
- NCT03073265
- Testing
- STA-Apixaban Calibrator & Control
- Where
- 2 sites in United States
- Volunteers
- 109 people
- Sponsor
- Diagnostica Stago
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.
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
Healthy Subjects
Definition and Validation of Normative Data of EndoFLIP™ Measurements in Healthy Subjects
Multicenter, Prospective, Non-Randomized clinical trial to define and validate normative data of EGJ-distensibility measurements and contractile patterns in healthy subjects.
- Trial name
- RUBY (NCT03831724)
- Testing
- EndoFLIP™ System with FLIP Topography Module
- Volunteers
- healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Healthy, Arrhythmia
Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Pulse Rate
The study will evaluate the mean average error (MAE) of measuring pulse rate using the Norbert Device (ND) as compared to a reference heart rate measured using an electrocardiogram (ECG).
- Trial name
- NCT05640323
- Testing
- Norbert Device
- Where
- 2 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Norbert Health
Myopia
Comparison of New Contact Lens With Current Marketed Lens
The purpose of this study is to validate the clinical performance of a new contact lens design.
- Trial name
- NCT03360110
- Testing
- Phoebe test lens, stenfilcon A lens (control)
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- CooperVision, Inc.