Clinical trials: Validation Studies
Infant Nutrition Disorders, Weight Loss
Feasibility and Validation of a Smart Changing Pad for Home Infant Weight Monitoring After Hospital Discharge
This pilot study evaluates the feasibility, usability, and clinical utility of the Woddle Smart Changing Pad and companion mobile application for infant monitoring following hospital or NICU discharge.
- Conditions
- Infant Nutrition Disorders, Weight Loss, Postnatal Care, Premature Birth
- Trial name
- NCT07718516
- Testing
- Woddle Smart Changing Pad
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- Stan Kachnowski
Cardiac Disease
Human Factors Study of Ultrasound Navigation Software for Cardiac Imaging
The Product is a machine learning software, that utilizes AI to provide real-time guidance to acquire diagnostic-quality ultrasound views of the heart.
- Trial name
- NCT05660044
- Where
- Israel
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- UltraSight
Melanoma, Melanoma, Skin
AI-based Medical Device Validation for Early Melanoma Detection
The goal of this observational study is to learn if a computer-aided diagnosis (CAD) system can help identify skin cancer (cutaneous melanoma).
- Trial name
- LEGIT_MC_EVCDA (NCT06221397)
- Testing
- AI-based Computer-Aided Diagnosis (CAD) Software for Skin Lesion Analysis.
- Where
- Spain
- Volunteers
- 105 people
- Sponsor
- AI Labs Group S.L
Allergic Asthma, Allergy to House Dust
Validation of Strasbourg Environmental Exposure Chamber ALYATEC in Mite Allergic Subjects With Asthma
This is a randomized, double blind, cross-over study designed to determine the concentration of airborne house dust mite allergen inducing bronchial response in asthmatic subjects allergic to mite, during allergen exposures in…
- Conditions
- Allergic Asthma, Allergy to House Dust, Allergy
- Trial name
- NCT04663880
- Testing
- Exposure to three concentrations of HDM allergen in EEC, Exposure to a single concentration of HDM allergen in EEC
- Where
- France
- Volunteers
- 27 people
- Sponsor
- Alyatec
Spine Disease, Spinal Fusion
Validity and Accuracy of a Machine Learning Predictive Model in the Exploitation of Patients Related Outcomes in Spine Surgery
The objective of the study is the establishment, optimization and prospective evaluation of a digital predictive platform capable of providing for each lumbar spine operated patient a clinical predictive status: Patient green…
- Conditions
- Spine Disease, Spinal Fusion, Surgery, Spine Degeneration
- Trial name
- DeepSurgery (NCT05166018)
- Testing
- SuMO Patient
- Where
- 2 sites in France
- Volunteers
- 174 people
- Sponsor
- Cortexx Medical Intelligence
Calibration and Validation of Analyte Testing System
A Human Clinical Study to Collect Calibration and Performance Data for the RBA-1 and KBS-1
The purpose of the Kaligia Biosciences KBS Systems 1.0(b) analyte monitoring device is to measure the blood analyte levels in patients.
- Trial name
- NCT04305938
- Testing
- Minimally invasive and non-invasive blood analyte measurement
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Kaligia Biosciences, LLC
COPD
Loop Band Validation Study
The main purpose of this study is to assess the accuracy of a non-invasive wearable technology in the form of a wristband.
- Trial name
- NCT03240926
- Testing
- Loop Band
- Where
- United States
- Volunteers
- 235 people, healthy volunteers welcome
- Sponsor
- Spry Health
Bladder Carcinoma, Prostate Tumor
Validation Study on the Removal of EpCAM-positive Tumour Cells From Blood Collected During Tumour Surgery Using Catumaxomab/Catuvab Device
The REMOVE study was an open-label, multicenter validation study on the removal of EpCAM-positive tumor cells from blood collected during tumor surgery using the CATUVAB Kit.
- Conditions
- Bladder Carcinoma, Prostate Tumor, Gallbladder Carcinoma, Endometrial Carcinoma
- Trial name
- REMOVE (NCT06789224)
- Testing
- CATUVAB
- Where
- 6 sites in Germany
- Volunteers
- 136 people
- Sponsor
- Lindis Bloodcare GmbH
Streptococcus Agalactiae Infection
Validation of the GenePOC GBS Assay for the Detection of the Cfb Gene From Streptococcus Agalactiae Strains
The primary purpose of this clinical investigation is to verify the performance of the GenePOC GBS Assay on the GenePOC Instrument.
- Trial name
- NCT02718157
- Testing
- Comparison between GenePOC PCR and Reference Method
- Where
- 4 sites in United States, Canada
- Volunteers
- 771 people
- Sponsor
- Meridian Bioscience, Inc.
PHYSIOLOGICAL PHENOMENA, Homeostasis
Truway Whole-Body Digital Twin and Physiologic Resilience Study (TRU-OMNIBODY)
TRU-OMNIBODY is a prospective observational study designed to develop and independently validate a research-only whole-body digital twin.
- Conditions
- PHYSIOLOGICAL PHENOMENA, Homeostasis, Physical Functional Performance, Cardiorespiratory Fitness
- Trial name
- TRU-OMNIBODY (NCT07805044)
- Testing
- Standardized Physiologic Resilience Challenge, Multimodal Whole-Body Physiologic Monitoring, Research-Only Whole-Body Digital Twin Analysis
- Where
- United States
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Truway Health, Inc.
COVID-19, Severe Respiratory Distress Syndrome
suPAR Michigan M2C2 Heterogeneity Validation Cohort Study
This is a retrospective, non interventional cohort study using stored plasma samples from appoximately 300 adults hospitalized with confirmed COVID 19.
- Conditions
- COVID-19, Severe Respiratory Distress Syndrome, Acute Respiratory Distress Syndrome
- Trial name
- NCT07466524
- Testing
- suPARnostic® TurbiLatex Assay on Roche cobas c501
- Where
- United States
- Volunteers
- 367 people
- Sponsor
- ViroGates A/S
Diabetic Retinopathy
AutoDx-DR Prospective Clinical Validation Study Protocol
In this study, we will prospectively evaluate the accuracy of a deep-learning based software algorithm in the detection of diabetic retinopathy from 60° wide single-field retinal fundus images.
- Trial name
- NCT04627272
- Testing
- AutoDX-DR
- Volunteers
- 1,539 people
- Sponsor
- Hill-Rom
Healthy, Hypertension
A Validation Study of Selfie Technology for Assessment of Vital Signs
The aim of this study is to compare accuracy of DocMe, a video technology developed by DocMe Health Technologies, with previously validated medical devices used for measurements of heart rate, heart rate variability, respiratory…
- Trial name
- NCT05117762
- Where
- United Kingdom
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- DocMe Technologies Ltd
Pulmonary Disease, Chronic Obstructive
Method Validation Study to Explore the Sensitivity of SenseWear Armband Gecko for Measuring Physical Activity in Subjects With Chronic Obstructive Pulmonary Disease (COPD) & Asthma
The prevalence, low cost, and low burden of wearable devices that provide quantitative and qualitative feedback on a subject's activity level present an opportunity for the use of these devices in clinical and observational…
- Trial name
- NCT02619357
- Testing
- SenseWear Armband Gecko, SenseWear Armband MF, Actigraph GT9x wristband and waistband
- Where
- United Kingdom
- Volunteers
- 22 people
- Sponsor
- GlaxoSmithKline
Pulse Oximetry, Oxygen Measurements, SpO2
SpO2 Validation Study-Philips Optimus
Validation study to validate the SpO2 accuracy performance of the Sponsor's SpO2 sensors over the range of 70-100% SaO2 during non-motion conditions assessed by CO-Oximetry
- Trial name
- NCT07215429
- Testing
- No intervention
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Blood Pressure
Fresenius Noninvasive Blood Pressure Validation
The purpose of this study to collect blood pressure measurement values from the blood pressure measurement device on the Fresenius machine as compared to the standard method.
- Trial name
- BPM2 (NCT04573595)
- Testing
- Blood Pressure Measurement
- Where
- United States
- Volunteers
- 159 people, healthy volunteers welcome
- Sponsor
- Fresenius Medical Care North America
Healthy Male Adults Participants, Vasectomy
Plan A Novel Delivery Device Study
This study will evaluate the safety and usability of the Delivery Lumen Access Device (DLAD) in accessing the vas deferens in up to 30 healthy males. This is a prospective, non-randomized, open label interventional study.
- Trial name
- NCT06891729
- Testing
- Delivery Lumen Access Device, DLAD
- Where
- 2 sites in Australia, Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Next Life Sciences
Vulvovaginal Candidiasis
VVC Sampling Study for Analysis Validation
This is a biomarker multi-centre study to validate an extraction method of fungal and bacterial DNA extracted from vaginal swabs from adult women with confirmed VVC.
- Trial name
- NCT05327192
- Testing
- No intervention, only sampling
- Where
- 2 sites in United Kingdom
- Volunteers
- 10 people
- Sponsor
- Gedea Biotech AB
Atrial Fibrillation (AF), Paroxysmal Atrial Fibrillation (PAF)
Multi-Centre Based Study Recognition of Atrial Fibrillation With the Corsano CardioWatch 287-2 System
This concerns a multi-center, single-arm, diagnostic accuracy study. In this study, a wristband that monitors heart rythm is assessed in clinical and free living conditions.
- Trial name
- COR-AF (NCT06955273)
- Testing
- Corsano CardioWatch 287-2
- Where
- Netherlands
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- Corsano Health B.V.
Bacterial Infections, Bacterial Infections and Mycoses
Large Algorithm Setting and Validation Study
In this pilot study, prospectively acquired clinician-collected and participant-collected vaginal swab specimens will be obtained from up to 1000 individuals with signs and symptoms of vaginitis to develop and validate a…
- Conditions
- Bacterial Infections, Bacterial Infections and Mycoses, Infections, Vaginitis
- Trial name
- LAVA (NCT07607470)
- Testing
- Nanopath Vaginitis Assay, BD Max™ Vaginal Panel, Cepheid Xpert® Xpress MVP
- Where
- 2 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Nanopath, Inc