Clinical trials: Validation
Healthy
Validation of Smart Garments for Gait Classification
The aim of this study is therefore to validate Myant SKIIN garments for the purpose of gait and balance assessment. To achieve this, we recruit young healthy adults from the University of Waterloo to wear Skiin products (see Fig.
- Trial name
- NCT05898555
- Testing
- Skiin garment and pods
- Where
- Canada
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Myant Medical Corp.
Subjects Presenting With Normal or With Ocular Pathology
Clinical Validation of New OCT System
To demonstrate clinical substantial equivalence of DRI OCT-1 as comparable to the commercially available Cirrus
- Trial name
- NCT01809704
- Where
- 3 sites in United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Topcon Medical Systems, Inc.
Bladder Disease, Bladder Retention Volume
ECHO-012 Kosmos Bladder Clinical Validation Study
The goal of this clinical trial is to compare the Kosmos Automatic Bladder Volume to the manual annotated bladder volume in participants across gender (male and female), age (children ages 7-17 and adults 18-89), and BMI strata…
- Conditions
- Bladder Disease, Bladder Retention Volume, Bladder Dysfunction, Bladder Function
- Trial name
- NCT06792851
- Testing
- Kosmos Bladder Volume Algorithm
- Where
- United States
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- EchoNous Inc.
Healthy, Arrhythmia
Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Pulse Rate
The study will evaluate the mean average error (MAE) of measuring pulse rate using the Norbert Device (ND) as compared to a reference heart rate measured using an electrocardiogram (ECG).
- Trial name
- NCT05640323
- Testing
- Norbert Device
- Where
- 2 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Norbert Health
Osteoporosis, Osteopenia
Bone UltraSonic Scanner (BUSS): Validation Study
The aim of clinical study is to assess effectiveness of Bone UltraSonic Scanner (BUSS) versus densitometry (DXA) in osteoporosis detection.
- Trial name
- NCT01439139
- Where
- United States
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Artann Laboratories
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
Hepatocellular Carcinoma
Refinement and Validation of a Diagnostic Model (GAMAD) for Early Detection of Hepatocellular Carcinoma
Most hepatocellular carcinoma (HCC) cases were at advanced stage when diagnosis established. This study is intended to establish a clinical diagnostic model GAMAD for early-stage HCC and evaluate the diagnostic efficiency the…
- Trial name
- NCT05626985
- Testing
- GAMAD
- Where
- 3 sites in China
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Singlera Genomics Inc.
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.
Gastroparesis
ABCA2 GIRMS Analytical Validation Clinical Performance Study
The purpose of this study is to collect human breath samples for use in a validation study intended to demonstrate equivalent clinical performance measures of new ABCA2 GIRMS (Automated Breath Carbon Analyzer-2 Gas Isotope Ratio…
- Trial name
- NCT04607304
- Testing
- ABCA2 GIRMS
- Where
- United States
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Cairn Diagnostics
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
Atrial Fibrillation
Clinical Validation of the Withings ECG Monitor for the Detection of Atrial Fibrillation
The aim of the study is to demonstrate the performance of Withings WBS08 in the automatic identification of atrial fibrillation and sinus rhythm.
- Trial name
- QDA-UE (NCT05266235)
- Testing
- Validation of the Withings bodyscan scale WBS08
- Where
- 4 sites in Belgium, France
- Volunteers
- 274 people, healthy volunteers welcome
- Sponsor
- Withings
Alzheimer Disease, Mild Cognitive Impairment
Software Validation Study-Cognitive Status Indicator
The SPARK Cognitive Status Indicator software uses an algorithm to assess a resting state EEG recording as being consistent with a cognitive status of unimpaired, mild cognitive impairment (MCI; MCI AD- or MCI AD+), or dementia…
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Dementia
- Trial name
- REMIND-V (NCT06809725)
- Testing
- SPARK Cognitive Status Indicator (software support data collected via EEG)
- Where
- United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Spark Neuro Inc.
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
Healthy, Hypoxia
Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Oxygen Saturation
The purpose of this study is to evaluate the SpO2 accuracy and performance of the Norbert Device during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-oximetry for SpO2…
- Trial name
- NCT05685654
- Testing
- Norbert Device
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Norbert Health
Alzheimer Disease, Mild Cognitive Impairment
Optina Diagnostics' Cerebral ß-Amyloid Status (CAS) Test
This observational, cross-sectional study is designed to validate a novel diagnostic test for the detection of phenotypic changes in the retina that correlate with likely PET amyloid status (negative or positive), to aid in the…
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Mild Dementia
- Trial name
- REPHRASE (NCT05107882)
- Where
- 7 sites in United States, Canada
- Volunteers
- 466 people, healthy volunteers welcome
- Sponsor
- Optina Diagnostics Inc.
Blood Pressure
Comparison of Non-Invasive Blood Pressure Methods
The primary objective of the study is to demonstrate the accuracy in healthy adults with Vital USA Device by comparison to a non-invasive (auscultatory) reference sphygmomanometer.
- Trial name
- NIBP (NCT04296227)
- Testing
- The Vital Detect blood pressure monitor
- Where
- United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Vital USA, Inc.
Hearing Loss
Clinical Validation of the Lexie Lumen Hearing Aid
More than half a billion people globally have hearing loss. Most hearing loss is sensorineural, meaning that the hearing loss is irreversible and requires rehabilitation.
- Trial name
- NCT05337748
- Testing
- Lexie Self Test and Fit Group, Lexie Professional Test and Fit Group
- Where
- South Africa
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- hearX Group
Heart Rate, Heart Rate Variability
Contactless Measurement of Heart Rate, Heart Rate Variability, Breathing Rate and Blood Pressure Using Remote Photoplethysmography
The purpose of this study it to evaluate the accuracy of heart rate, heart rate variability, breathing rate and blood pressure measurement with the use of Shen.AI software.
- Conditions
- Heart Rate, Heart Rate Variability, Breathing Rate, Blood Pressure
- Trial name
- NCT06829615
- Testing
- Shen.AI
- Where
- 2 sites in Poland
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- SHEN.AI spółka z ograniczoną odpowiedzialnością oddział w Polsce
Healthy
Validation Study of Mean Arterial Pressure (MAP) Parameter of Masimo INVSENSOR00073
The aim of the study is to validate the Mean Arterial Pressure (MAP) parameter of Masimo INVSENSOR00073 against the gold standard blood pressure measurements from the arterial line while subject undergo a blood pressure variation…
- Trial name
- NCT06334055
- Testing
- Masimo INVSENSOR00073
- Where
- United States
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Heart Failure, High Blood Pressure
BVA-200 vs BVA-100 Validation Study
The proposed study is a prospective, observational, investigator and patient blinded study comparing the results of blood volume measurement using the FDA-cleared Daxor BVA-100 device to the Daxor BVA-200 device.
- Conditions
- Heart Failure, High Blood Pressure, High Cholesterol, Anemia
- Trial name
- NCT06227819
- Testing
- BVA-200
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Daxor Corporation