Clinical trials: Validation Studies
Device Validation of In-vivo Performance
Trima Non-DEHP Leukoreduced Red Blood Cell In Vivo Recovery Study
This is an in vivo 24-hour in-vivo recovery study of leukoreduced red blood cells (RBCs) collected on the Trima Accel System using Non-DEHP disposable sets and stored for 42 days.
- Trial name
- NCT06602804
- Testing
- Trima Accel Auto RBC Collection
- Where
- 2 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Terumo BCT
Helicobacter Pylori Infection
Exalenz Lab Mode System Compared to Biopsy for H.Pylori Detection
The Exalenz Dual Mode BreathID® Hp System comprised of IDkit: Hp™ TWO and the Dual Mode BreathID® Hp test device will be used to perform a urea breath test in the initial diagnosis and post treatment monitoring of H.pylori…
- Trial name
- NCT02528721
- Testing
- Dual Mode BreathID Hp System
- Where
- 13 sites in United States, Israel
- Volunteers
- 282 people
- Sponsor
- Meridian Bioscience, Inc.
Sleep-disordered Breathing
ApneaLink Air Home Sleep Testing (HST) Device Validation Study
This study compares the diagnostic capability of a home sleep apnea testing device to polysomnography.
- Trial name
- NCT03470493
- Testing
- ApneaLink Air
- Where
- 2 sites in United States
- Volunteers
- 130 people
- Sponsor
- ResMed
SpO2 (Peripheral Oxygen Saturation) Measurement Validation
Philps FAST2022 picoSAT Pulse Oximetry Desaturation Study
Validation study to compare the accuracy of non-invasive Philips SpO2 sensors in detecting blood oxygen levels compared to invasive methods requiring a blood draw and lab analysis.
- Trial name
- NCT05683366
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Volunteers, Study Focus: Blood Pressure Measures
Valid-B.Well BP25 Study
Prospective, single-center, single-arm, open, comparative, validation of a commercialized device, repeated measures accuracy study designed in accordance with the requirements of the ISO 81060-2:2018 AAMI/ESH/ISO Universal…
- Trial name
- NCT07340957
- Testing
- Blood pressure measurement
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- B.Well Swiss AG
Atrial Fibrillation
Atrial Fibrillation Algorithms Clinical Validation Study
The purpose of the study is to evaluate the performances of investigational Irregular Rhythm Notification Feature (version 2.0) and Atrial Fibrillation History Feature algorithms.
- Trial name
- NCT04699812
- Testing
- ELECTROCARDIOGRAM (ECG) PATCH WEAR
- Where
- 4 sites in United States
- Volunteers
- 573 people, healthy volunteers welcome
- Sponsor
- Apple Inc.
Atrial Fibrillation
Electrocardiogram Clinical Validation Study
The purpose of the study is to confirm the software's ability to create a Lead-1 electrocardiogram (ECG) that is clinically equivalent to a reference device.
- Trial name
- NCT03492554
- Testing
- 1-Lead ECG, 12-Lead ECG
- Where
- 5 sites in United States
- Volunteers
- 602 people, healthy volunteers welcome
- Sponsor
- Apple Inc.
A Minimum of 30 Adults, Ages 18 Years and Older
Respiratory Rate Validation Study - RS001.2 Respiree Cardio-Respiratory Monitor
The purpose of this study is to conduct a Respiratory Rate accuracy validation comparing the RS001.2 Respiree Cardio-Respiratory Monitor to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda).
- Trial name
- NCT05210712
- Testing
- RS001.2 Respiree Cardio-Respiratory Monitor
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Respiree Pte Ltd
Phenylketonuria (PKU) and Hyperphenylalaninemia
PheCheck™ Validation Study
The goal of this observational study is to evaluate the performance of the PheCheck™ test for the rapid detection of phenylalanine (Phe) from a fingerstick sample, in patients 1 year or older with phenylketonuria (PKU) or…
- Trial name
- NCT07551921
- Testing
- PheCheck, Dried Blood Spot Cards.
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Aptatek BioSciences, Inc
Arrythmia
Electrocardiogram (ECG) Validation Study
Comparison of diagnostic Electrocardiogram (ECG) signals
- Trial name
- NCT06414447
- Testing
- Huxley Medical
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Huxley Medical, Inc.
Cartilage Damage
Advanced Cartilage Treatment With Injectable-hydrogel Validation of the Effect
Multicentre, pivotal, non-randomized, prospective, open-label clinical investigation involving a new hydrogel, Hy2Care Injectable hydrogel, developed by Hy2Care B.V., Enschede, The Netherlands (hereafter referred to as "Hy2Care")…
- Trial name
- ACTIVE (NCT05186935)
- Testing
- Injectable Hydrogel treatment
- Where
- Netherlands
- Volunteers
- 50 people
- Sponsor
- Hy2Care BV
Atrial Fibrillation
Withings ECG-app Study
The aim of the study is to evaluate the performance of Withings HWA10 with embedded Withings ECG-app in the automatic detection of atrial fibrillation
- Trial name
- NCT05316350
- Testing
- Electrocardiogram recording
- Where
- 10 sites in United States, France
- Volunteers
- 685 people
- Sponsor
- Withings
Healthy
Validation of the Stability of Diagnostic Biomarkers on Healthy Volunteers
Stability studies on the peripheral biomarkers (lncRNAs, sncRNAs, mRNAs, proteins, lipids/metabolites) measured by Firalis IVD test candidates and effect of gender, age, nutrition on their expression level
- Trial name
- NCT05160337
- Testing
- Biomarker based IVD tests
- Where
- France
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Firalis SA
Menstruation
Tampon Design Validation Study
This prospective multi-center, open-label, randomized, cross-over study is designed to validate the user needs of a tampon design. The hypothesis is that user needs are met.
- Trial name
- NCT05553600
- Testing
- Tampon BR, Tampon CR, Tampon BS
- Where
- 9 sites in United States
- Volunteers
- 732 people, healthy volunteers welcome
- Sponsor
- Kimberly-Clark Corporation
Sepsis, Septic Shock
Assessment of Heparin Binding Protein for the Prediction of Severe Sepsis
The purpose of this prospective, non-interventional, multi-centre clinical study is to assess the clinical validity of the Heparin Binding Protein (HBP) assay for indicating the presence, or outcome, of severe sepsis (including…
- Conditions
- Sepsis, Septic Shock, Sepsis With Acute Organ Dysfunction
- Trial name
- NCT03113721
- Where
- 5 sites in United States
- Volunteers
- 571 people
- Sponsor
- Axis Shield Diagnostics Ltd
Alzheimer Disease, Dementia
A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)
The main goals of this study are to further determine whether the study drug donanemab is safe and effective in participants with Alzheimer's disease and to validate neuropsychological assessments administered over…
- Conditions
- Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases
- Trial name
- NCT04640077
- Testing
- No Intervention, donanemab
- Where
- 27 sites in United States, Canada
- Volunteers
- 95 people
- Sponsor
- Eli Lilly and Company
Performance and Safety
Clinical Study of CT 5400 RT for System Validation
The purpose of this clinical trial is to evaluate the efficacy and safety of the CT 5400 RT System.
- Trial name
- NCT06466577
- Testing
- CT 5400 RT System
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Unipolar Depression, Major Depressive Disorder (MDD)
Validation of EmoDTx as a Digital Endpoint for Mood Monitoring in Adult Patients Suffering From Unipolar Depression
The aim of this study is to validate the EmoDTx as a digital tool for mood monitoring in adult patients with unipolar depression. The study is prospective, multicenter, and observational, with a single-arm approach.
- Conditions
- Unipolar Depression, Major Depressive Disorder (MDD), Depression
- Trial name
- EMC2FR (NCT06860165)
- Where
- 2 sites in France
- Volunteers
- 98 people
- Sponsor
- Emobot
Breast Cancer
Validation Study Using the GeneSearch BLN Assay to Test Sentinel Lymph Nodes From Patients With Breast Cancer
The purpose of this trial is to show adequate assay performance on clinical samples tested in real time at the clinical site.
- Trial name
- NCT00551278
- Testing
- GeneSearch™ Breast Lymph Node (BLN) Assay
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Janssen Diagnostics, LLC
Carbapenem-Resistant Enterobacteriaceae
Clinical Validation of the Molecular-Based GenePOC Carba Assay for the Detection and Differentiation of Carbapenemase Genes in Rectal Swab Samples.
The primary purpose of this clinical investigation is to establish the performance of the GenePOC Carba assay on the revogene. This will be achieved by comparing the test to a conventional method for detection of Carbapenemase…
- Trial name
- NCT03680898
- Testing
- Rectal swab collection
- Where
- 3 sites in United States, Canada
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Meridian Bioscience, Inc.