Clinical trials: VALİDİTY
Hypoxia
Controlled Desaturation Study for TipTraQ SpO2 Performance Validation
The objective is to validate the performance of SpO2 measurement of the TipTraQ by comparing it with measurement from an artery blood sample of a healthy volunteer in a controlled desaturation study.
- Trial name
- NCT06634693
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- PranaQ Pte. Ltd.
Skin Lesion, Traumatic Ulcer
Clinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions
The aim of this clinical investigation is to collect skin lesion area data for the comparison of the agreement among the results obtained between the following three wound area measurement methods: Ruler using the Kundin method…
- Conditions
- Skin Lesion, Traumatic Ulcer, Hematoma, Pressure Ulcer
- Trial name
- NCT05729334
- Testing
- Clinicgram Euclides
- Where
- Spain
- Volunteers
- 65 people
- Sponsor
- Skilled Skin S.L.
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
Healthy, Sleep Deprivation
Smart Sleep In-home Validation Extension Study
This study is a nonrandomized, unblinded, uncontrolled case series clinical trial validating the SmartSleep product, including SleepMapper app in the home setting.
- Conditions
- Healthy, Sleep Deprivation, Insufficient Sleep Syndrome
- Trial name
- NCT03665844
- Testing
- SmartSleep Boost On, SmartSleep Boost Off
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Philips Respironics
Precise Image (AI Reconstruction Feature of CT 5400 RT System)
Clinical Study of CT 5400 RT for Precise Image Validation
The purpose of this study is to evaluate the effectiveness of the Precise Image (PI), an AI feature of CT 5400 RT System
- Trial name
- NCT06589934
- Testing
- Precise Image
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Blood Pressure
Data Collection for Validation of an NIBP Algorithm in Pregnant Women
The purpose of the study is to collect per subject blood pressure data on the device's intended population as described in the International Organization for Standardization (ISO) Standard 81060-2:2018+A1:2020 Non-invasive…
- Trial name
- NCT05789849
- Testing
- Collecting blood pressure measurements with noninvasive blood pressure device
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- GE Healthcare
Sepsis
Clinical Validation of BACTEC™ Plus Aerobic/F Culture Vials Compared With Equivalent Product
This study is a multi-center, randomized clinical validation. Subjects should be fully informed of this protocol and related risks, and can only be enrolled into this study after signing the informed consent form.
- Trial name
- NCT06426121
- Testing
- test Aerobic/F Culture Vials, control Aerobic/F Culture Vials
- Where
- China
- Volunteers
- 394 people
- Sponsor
- Becton, Dickinson and Company
Respiratory Complication
Vital USA Respiratory Rate Validation In Adults
Vital USA is dedicated to developing and applying innovative electronic medical solutions that improve patient care in multiple clinical settings.
- Trial name
- RR (NCT04292639)
- Testing
- The Vital Detect Pulse Oximeter
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Vital USA, Inc.
Post Cardiac Surgery Patients
Measurement of Cardiac Output and Blood Volumes Using Transonic Ultrasound Dilution Technology
Measurement of the amount of blood pumped by the heart (cardiac output) and blood volumes in sick patients is important for doctors to better treat these patients.
- Trial name
- NCT00756119
- Where
- Russia
- Volunteers
- 26 people
- Sponsor
- Transonic Systems Inc.
Respiratory and Pulse Rate Accuracy Validation
Binah.ai Visual Vitals Application - Validation Study
The purpose of this study is to conduct a Respiratory and Pulse Rate accuracy validation comparing the Binah.ai Visual Vitals Application to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda), and a…
- Trial name
- NCT05539612
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Binah.ai LTD.
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.
Cancer
Entia Liberty: Usability Validation
This study forms part of Entia's clinical evidence for regulatory submission. This study evaluates Entia Liberty's validation of the device.
- Trial name
- NCT05027256
- Testing
- Entia Liberty
- Where
- 2 sites in United Kingdom
- Volunteers
- 30 people
- Sponsor
- Entia Ltd
Malignant Skin Melanoma T0, Basal Cell Carcinoma
DERM US and EU Validation Study
This study aims establish the effectiveness of Image Analysing Algorithm (DERM) to identify melanoma, Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC) when used to analyse dermoscopic images of skin lesions within the…
- Conditions
- Malignant Skin Melanoma T0, Basal Cell Carcinoma, Squamous Cell Carcinoma
- Trial name
- NCT05126173
- Testing
- Deep Ensemble for the Recognition of Malignancy (DERM)
- Where
- 16 sites in United States, Italy
- Volunteers
- 1,111 people
- Sponsor
- Skin Analytics Limited
NAFLD, NASH - Nonalcoholic Steatohepatitis
Development and Validation of a Multi-target, Blood-based NAFLD Diagnosis Test
Multi-omics approach was used to identify patterns of serological biomarkers to diagnose NAFLD. The purpose of this study is to develop and validate a blood-based assay to diagnose NAFLD by collecting blood sample from healthy…
- Trial name
- NCT05108415
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- HBI Solutions Inc.
Bone Diseases, Image
Clinical Validation of BoneMRI in the Spine
BoneMRI is a quantitative 3D MRI technique that has been developed recently by MRIGuidance BV©, which is based on a multiple gradient-echo sequence and a machine learning processing pipeline.
- Conditions
- Bone Diseases, Image, Medical Device
- Trial name
- CleverBones (NCT06745791)
- Testing
- BoneMRI
- Where
- 10 sites in Belgium, France and 2 more
- Volunteers
- 450 people
- Sponsor
- MRIguidance B.V.
Flushing
Endpoint Validation Study (0524A-015)
To determine the most effective daily dose of MK0524A when compared with placebo after the 8-week treatment period for Niacin Induce Flushing (NIF).
- Trial name
- NCT00533676
- Testing
- MK0524A, /Duration of Treatment : 8 Weeks
- Volunteers
- 165 people
- Sponsor
- Merck Sharp & Dohme LLC
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
COPD
Validation of a Digital Platform for Functional Respiratory Rehabilitation
Chronic Obstructive Pulmonary Disease (COPD), characterized by persistent airflow limitation in the respiratory airways, is a chronic condition that affects millions of people worldwide.
- Trial name
- ReHub (NCT06252818)
- Testing
- ReHub
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Bio-Sensing Solutions S.L. (DyCare)
Diabetes Mellitus, Type 2
Evogliptin in Type 2 Diabetes Mellitus (EVOLUTION: EVOgLiptina no Diabetes Mellitus TIpO 2)
This phase II, multicenter, randomized, double-blind, double-dummy study with four parallel treatment groups, with active control, will be performed only in brazilian sites under the sponsorship of Eurofarma Laboratórios S.A..
- Trial name
- EVOLUTION (NCT02689362)
- Testing
- Evogliptin, Sitagliptin
- Where
- 10 sites in Brazil
- Volunteers
- 146 people
- Sponsor
- Eurofarma Laboratorios S.A.
SARS-CoV-2 Infection, Influenza A
Clinical Validation of an At-Home Flu A/B and COVID-19 Rapid Test
The study's primary objective is to evaluate the performance of the CorDx Tyfast Flu A/B \& COVID-19 At-Home Test for detecting SARS-CoV-2, Influenza A, and B in nasal samples collected by lay users, compared to 510(k)-cleared…
- Conditions
- SARS-CoV-2 Infection, Influenza A, Influenza B
- Trial name
- NCT07430410
- Testing
- CorDx Tyfast Flu A/B & COVID-19 At-Home Multiplex Rapid Test
- Volunteers
- 200 people
- Sponsor
- CorDx, Inc.