Clinical trials: VALİDİTY
Neuropathy, Diabetic, Neuropathy;Peripheral
Clinical Efficacy and Human Factors Validation Testing of the Erchonia EVRL for Providing Temporary Relief of Diabetic Peripheral Neuropathy Foot Pain
The purpose of this clinical study is to determine the effectiveness of the Erchonia® EVRL™, manufactured by Erchonia Corporation (the Company), in providing prescription home use application for temporary relief of diabetic…
- Conditions
- Neuropathy, Diabetic, Neuropathy;Peripheral, Neuropathy, Painful
- Trial name
- NCT05291975
- Testing
- Erchonia® EVRL™
- Where
- 4 sites in United States
- Volunteers
- 64 people
- Sponsor
- Erchonia Corporation
Prostate Cancer Detection
Prostate Cancer Risk Identification in a Multi-Ethnic Cohort: a Prospective US-based Multi-center Validation Study of Proclarix
The study is a prospective, multi-center, single cohort study involving up to 10 urological clinics in the US. After provision of informed consent, up to 20 mL of whole blood will be collected from each subject.
- Trial name
- PRIME (NCT07543757)
- Testing
- Proclarix
- Where
- 7 sites in United States
- Volunteers
- 500 people
- Sponsor
- Sequenom, Inc.
Pulmonary Disease, Chronic Obstructive
Effects of a 9-months Treatment of SPIRIVA on Health Related Quality of Life in Patients With COPD
The purpose of this study is to investigate the effect of a 9-month treatment of tiotropium (SPIRIVA®) 18 mcg once daily on Health Related Quality of Life and lung function in patients with a Chronic Obstructive Pulmonary Disease.
- Trial name
- NCT00274053
- Testing
- tiotropium
- Where
- 27 sites in France
- Volunteers
- 555 people
- Sponsor
- Boehringer Ingelheim
COVID-19
Detection of COVID-19 Using Breath Analysis - Validation Study.
Detection of the 2019 novel Coronavirus (SARS-CoV-2) using breath analysis - Validation study.
- Trial name
- NCT05224622
- Testing
- VOX
- Where
- Israel
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- Scentech Medical Technologies Ltd
Atrial Fibrillation
ECG App Algorithms Clinical Validation Study
The purpose of the study is to evaluate the performance of ECG classification algorithms and their ability to classify heart rhythms into multiple categories of rhythms and heart rates
- Trial name
- NCT04247581
- Testing
- 1-lead ECG
- Where
- 4 sites in United States
- Volunteers
- 546 people, healthy volunteers welcome
- Sponsor
- Apple Inc.
Preeclampsia (PE)
Validation of the MaiRa Preeclampsia Test for Screening Early/Late Preeclampsia in First and Second Trimesters
Preeclampsia (PE) is a major obstetric complication with severe short- and long-term consequences for both mother and fetus. Early detection is critical to mitigate PE-related morbidity and mortality.
- Trial name
- iPregnostic (NCT06716242)
- Testing
- Peripheral blood collection
- Where
- 11 sites in Spain
- Volunteers
- 7,473 people
- Sponsor
- iPremom
Chest Pain
Low Dose One-Day Tc99m Protocol With a High-Efficiency Cardiac Dedicated Gamma Camera For Detection of Coronary Disease
A prospective single clinical trial to validate the use of a low-dose (~5mSv) Tc-99m protocol with a high-efficiency cardiac dedicated camera (Dynamic Single Photon Emission Computed Tomography; D-SPECT) to detect myocardial…
- Trial name
- NCT01135095
- Testing
- low-dose imaging
- Where
- 2 sites in United States
- Volunteers
- 101 people
- Sponsor
- Spectrum Dynamics
Brain Injuries, Concussion, Mild
Evaluation and Validation of a Multimodal Brain Function Biomarker With NPC
This study is designed to collect data which will be used to associate changes in EEG, neurocognitive performance, eNPC and clinical symptoms in concussion subtypes.
- Conditions
- Brain Injuries, Concussion, Mild, Concussion, Brain, Near Point Convergence
- Trial name
- BSC-CI-NPC (NCT04074486)
- Testing
- BrainScope Ahead 300iP-O, SCAT5, Near Point Convergence
- Where
- 6 sites in United States
- Volunteers
- 1,318 people, healthy volunteers welcome
- Sponsor
- BrainScope Company, Inc.
Validation of Oximeter System
Correlation of Venous Oxygen Saturation Measurements by Non-invasive Mespere Venous Oximeter and Central Venous Catheter
The purpose of this study is to establish the accuracy of the non-invasive Mespere Oximeter that estimates venous oxygen saturation.
- Trial name
- NCT01908790
- Testing
- Mespere Venous Oximeter, Avoximeter 4000
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Mespere Lifesciences Inc.
Obstructive Sleep Apnea
Workflow Validation of an In-Home Feedback Controlled Mandibular Positioner
The purpose of the study is to test the workflow of the MATRx and MATRx plus feedback controlled mandibular positioner in its intended setting and considerations related to decision making by the care provider.
- Trial name
- NCT03616327
- Testing
- MATRx in-lab, MATRx plus
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Zephyr Sleep Technologies
Febrile Illness, Healthy
NC Thermometer (Gen 3) ISO 80601-2-56 Validation
The purpose of this clinical validation is to evaluate the the clinical bias, the limits of agreement, and the clinical repeatability of measuring oral temperature using a new thermometer, NC° Thermometer (Gen 3), compared to a…
- Conditions
- Febrile Illness, Healthy, Fever
- Trial name
- NCT05721131
- Testing
- NC° Thermometer (Gen 3)
- Where
- 2 sites in United States
- Volunteers
- 105 people
- Sponsor
- Natural Cycles
Heart Failure, Kidney Disease
Neck-Worn Monitoring Sensor for - A Study for Monitoring Subjects With Fluid-Management Issues During Dialysis
The study has two objectives based on the intended-use measurements and populations described above. The first objective is to show that relative changes in impedance as measured by the test device (ΔSFI) are strongly correlated…
- Trial name
- NCT02140905
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- Baxter Healthcare Corporation
Temperature Change, Body
Validation of the Measurement Accuracy of the Tcore Thermometer
The aim of the study conducted at the UKSH is to investigate the measuring accuracy of the body core temperature thermometer Tcore®.
- Trial name
- T-CORE-PMCF (NCT04489927)
- Testing
- Tcore
- Where
- Germany
- Volunteers
- 75 people
- Sponsor
- Drägerwerk AG & Co. KGaA
Sleep-disordered Breathing (SDB), Sleep Apnea
Validation of the Smart Mask V1 System and Its Measurements of SpO2 and Pulse Rate
The goal of this clinical study is to investigate a new medical device, the Smart Mask V1 System (herein 'Smart Mask'), and particularly its measurements of blood oxygen levels (SpO2) and pulse rate (PR) in healthy adults aged 18…
- Conditions
- Sleep-disordered Breathing (SDB), Sleep Apnea, Sleep Quality
- Trial name
- SMV1: PPG (NCT07086742)
- Testing
- Smart Mask V1 System
- Where
- Belgium
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Pathway Medtech, LLC.
Adnexal Mass, Ovarian Cancer
Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy
Venn Biosciences Corporation ("InterVenn") has developed a liquid biopsy that is capable of distinguishing benign from malignant masses in women presenting with adnexal (pelvic) masses, through a simple blood test.
- Conditions
- Adnexal Mass, Ovarian Cancer, Pelvic Mass
- Trial name
- VOCAL (NCT03837327)
- Where
- 26 sites in United States, Australia and 2 more
- Volunteers
- 1,025 people
- Sponsor
- Venn Biosciences Corporation
Malaria
Clinical Performance Evaluation of Fyodor Urine Malaria Test (UMT)
The purpose of this study is to evaluate the clinical performance of the one-step Fyodor Urine Malaria Test (UMT), to determine its accuracy (sensitivity and specificity) for the diagnosis of Plasmodium falciparum malaria in…
- Trial name
- NCT01921413
- Testing
- Urine Malaria Test
- Where
- Nigeria
- Volunteers
- 1,893 people, healthy volunteers welcome
- Sponsor
- Fyodor Biotechnologies Inc
Leg Ulcer, Diabetic Foot Ulcer
Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia
The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing performance properties is fulfilled and that the dressing is safe when used on wound types such as pressure ulcer, leg ulcer, and diabetic…
- Conditions
- Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer
- Trial name
- NCT01966380
- Testing
- Leia
- Where
- Sweden
- Volunteers
- 6 people
- Sponsor
- Molnlycke Health Care AB
Alzheimer's Disease
Evaluation of Physician Training Methods to Read Florbetapir-PET Scans
The purpose of this study is re-read of brain amyloid positron emission tomography (PET) scans acquired in previous florbetapir F 18 clinical studies by readers trained using updated reading methodology.
- Trial name
- NCT01565369
- Testing
- florbetapir F 18
- Volunteers
- 35 people
- Sponsor
- Avid Radiopharmaceuticals
Sleep Disorder, Nightmare
Validation of the Sleep Assessment Algorithm in the Medical Application Nightly
The Nightly medical application prototype is a potential, non-invasive class I medical device. The application has the potential to combine both diagnostic and therapeutic procedures for sleep.
- Trial name
- NCT03532269
- Testing
- Nightly App
- Where
- Poland
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- DreamJay Sp. z o. o.
Chronic Obstructive Pulmonary Disease (COPD)
WearME-Pro Phase II: Remote Use Usability and Longitudinal Validation Study (Patch Form Factor).
This Phase II investigation evaluates the safety, usability, and clinical performance of the WearME-Pro patch system for remote monitoring of adults with COPD in a home-use environment.
- Trial name
- WearME-Pro (NCT07430605)
- Testing
- WearME-Pro Patch System, FDA-cleared handheld spirometer (reference comparator), Cardea SOLO ECG patch (optional subset; exploratory HR reference)
- Where
- 3 sites in United States
- Volunteers
- 82 people
- Sponsor
- LASARRUS Clinic and Research Center