Clinical trials: VALİDİTY
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
Endometriosis (Diagnosis), Blood Biomarkers
EndoSearch : Endometriosis Biomarkers
EndoSearch aims to analytically validate a cluster of specific biomarkers for endometriosis diagnosis and disease recurrence. This signature will be tested on endometrium and blood from 975 patients, divided in two groups : 550…
- Conditions
- Endometriosis (Diagnosis), Blood Biomarkers, Endometrium Biomarkers
- Trial name
- NCT03376451
- Testing
- Assessment of endometrium and blood biomarkers for endometriosis diagnosis
- Where
- France
- Volunteers
- 975 people, healthy volunteers welcome
- Sponsor
- Dr Afchine Fazel
Influenza A, Influenza B
Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B
The primary purpose of this study is to validate the sensitivity and specificity of the Respirio Flu Test in detecting Influenza A, when used by subjects, as compared to the gold standard for detection, Reverse Transcriptase…
- Trial name
- NCT02487173
- Testing
- Respirio Flu Test, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Sofia® Influenza A+B Fluorescent Immunoassay (FIA)
- Where
- 4 sites in Australia
- Volunteers
- 83 people
- Sponsor
- Ellume Pty Ltd
Sarcopenia, Body Composition
Validation of a Body-Composition Segmentation Software on a Diverse Public CT Scan Cohort
This study evaluates the standalone performance of Soma, a deep-learning software developed by Nucleo Research, Inc. for the automated segmentation of body-composition tissues (skeletal muscle, subcutaneous adipose tissue…
- Conditions
- Sarcopenia, Body Composition, Obesity
- Trial name
- SOMA (NCT07600866)
- Testing
- Soma Body-Composition Segmentation Software
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Nucleo Research, Inc.
Severe to Profound Mixed Hearing Loss
Clinical Assessment of the External Sound Processor Worn by Patients Implanted With Codacs
The purpose of this study is to evaluate the effect of the sound processor upgrade from the C-DACS investigational device Freedom sound processor to the Nucleus® CP810 sound processor for the Codacs™ system on the speech…
- Trial name
- NCT02156167
- Testing
- CP810 and Codacs™ system test
- Where
- Germany
- Volunteers
- 15 people
- Sponsor
- Cochlear
Cancer
Entia Liberty: Capillary Validation
This study is a clinical performance validation study to evaluate the performance of the Entia Liberty device. Patients undergoing routine venepuncture blood tests will be recruited to have an Entia Liberty test (by finger-prick)…
- Trial name
- NCT05025111
- Testing
- Entia Liberty
- Where
- 2 sites in United Kingdom
- Volunteers
- 150 people
- Sponsor
- Entia Ltd
Atrial Fibrillation
Validation Study of Frontier X Plus (FX+) Device
The main objective of this study is to validate the specificity and sensitivity of FX+ detecting atrial fibrillation (AF) in both AF and non-AF subjects using a comparative approach, which involves using both a US FDA-cleared…
- Trial name
- NCT06471764
- Testing
- FX+ and 12-Lead ECG Recording
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Fourth Frontier Technologies Pvt Ltd.
Hypertension, Pre-eclampsia
Clinical Validation of the Blood Pressure Measuring Device Withings BPM Pro 2 in Pregnancy and Pre-Eclampsia
The aim of the study is to assess the accuracy of the automatic oscillometric BP measuring device at the brachial level, the WITHINGS BPM Pro 2, in pregnancy and pre-eclampsia
- Trial name
- WIHYP-PW (NCT07595016)
- Testing
- Blood pressure measurement
- Where
- Armenia
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Withings
Breast Cancer
ThermoBreast - Non-contact Breast Cancer Imaging Using AI-enhanced Thermography.
Breast cancer is one of the most worrisome health concerns facing women. Early detection and active patient monitoring are crucial to survival. The chances of a cure are high when detected and treated in the early stages.
- Trial name
- ThermoBreast (NCT06266026)
- Testing
- ThermoBreast - AI-based evaluation of dynamic breast thermography imaging
- Where
- Germany
- Volunteers
- 28,000 people, healthy volunteers welcome
- Sponsor
- ThermoMind Ltd.
Hemiplegia
Atalante USAbility
The "USAbility" study - Human Factor Validation Testing of the Atalante exoskeleton aims at demonstrating that Atalante can be used by the intended users without serious use errors or problems, for the intended uses and under the…
- Trial name
- NCT05284708
- Testing
- Atalante
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Wandercraft
Infiltration of Peripheral IV Therapy
ivWatch SmartTouch Sensor: Device Validation for Non-Infiltrated Tissues
A single arm study of 40 adult volunteers to assess the safety and efficacy of the ivWatch SmartTouch and fiber optic sensors when observing non-infiltrated (normal) tissues at common peripheral IV therapy sites.
- Trial name
- NCT04065373
- Testing
- ivWatch Model 400 with SmartTouch and fiber optic sensor
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- ivWatch, LLC
Brain Injuries, Traumatic, Concussion, Mild
Validation of Brain Function Assessment Algorithm for mTBI/Concussion in College Athletes
This study is Part 1 of data collection from 18-25 years old subject population for validation of previously derived algorithms.
- Conditions
- Brain Injuries, Traumatic, Concussion, Mild, Concussion, Brain, Concussion, Severe
- Trial name
- CASVAL (NCT02957461)
- Testing
- BrainScope Ahead 200iD
- Where
- 8 sites in United States
- Volunteers
- 420 people
- Sponsor
- BrainScope Company, 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.
Right Heart Catheterization
The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output
The Nanowear SimpleSense study is a single center, prospective, non-randomized, feasibility, non- significant risk study The study will be done in 2 phases.
- Trial name
- NCT05629533
- Testing
- SimpleSense
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Nanowear Inc.
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
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.
Anesthesia
A Study to Evaluate the Accuracy of aTCI Model of Cipepofol in Patients With General Anesthesia During Elective Surgery
This study is a multi-center (each center independently conducts the study according to the same research protocol), randomized, and open-label clinical study.
- Trial name
- NCT06740201
- Testing
- Cipepofol
- Where
- 2 sites in China
- Volunteers
- 40 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Prostate Cancer, Prostate Cancer Screening
Validation of ClarityDX Prostate as a Reflex Test to Refine the Prediction of Clinically-significant Prostate Cancer
This ambispective observational cohort study will evaluate the clinical performance of the ClarityDX Prostate blood test in men with a prostate-specific antigen (PSA) level of 3 ng/mL or higher who are undergoing prostate biopsy…
- Conditions
- Prostate Cancer, Prostate Cancer Screening, Performance Assessment of Novel Test
- Trial name
- APCaRI-05 (NCT03957252)
- Where
- 3 sites in United States, Canada
- Volunteers
- 2,800 people
- Sponsor
- Nanostics
Hearing Loss
Validation of Novel BTE and SP Hearing Aid Models
Participants will wear one set of 2 different BTE hearing aid models based on the gain required by their hearing loss. The hearing aids will be programmed based on a prescriptive approach and participants will be sent out for…
- Trial name
- NCT04882787
- Testing
- BTE hearing aid
- Where
- Canada
- Volunteers
- 14 people
- Sponsor
- Sonova AG
Absence Seizures, Absence Epilepsy
ECV - Epihunter Clinical Validation
The goal of this prospective study is to validate a wearable EEG seizure detection solution compared to video EEG. Subjects that undergo a clinical video EEG are asked to additionally wear a wearable EEG headband for up to 2…
- Trial name
- ECV (NCT04615442)
- Testing
- Epihunter
- Where
- 4 sites in United States, Belgium and 2 more
- Volunteers
- 102 people
- Sponsor
- Epihunter NV