Clinical trials: VALİDİTY
Sleep Apnea
Validation of a Contactless Vital Signs Measurement Sensor
The primary aim of this study is to validate the performance of Sleepiz One+ for the measurement of vital physiological parameters in adult population, against a laboratory-based polysomnography.
- Trial name
- NCT04676191
- Testing
- Sleepiz One+, Polysomnography
- Where
- Switzerland
- Volunteers
- 64 people
- Sponsor
- Sleepiz AG
Fever, Respiratory Tract Infections
A Retrospective, Blinded Validation of a Host-response Based Diagnostics
This is a retrospective, blinded, external validation study of a novel in-vitro diagnostic (IVD) assay that will include samples that were previously collected from febrile pediatric patients.
- Conditions
- Fever, Respiratory Tract Infections, Urinary Tract Infections, Gastroenteritis
- Trial name
- PATHFINDER (NCT01911143)
- Where
- 2 sites in Israel
- Volunteers
- 600 people
- Sponsor
- MeMed Diagnostics Ltd.
Cancer Colon, Cancer, Liver
Clinical Validation of an MCED Test in Symptomatic Populations (K-ACCELERATE)
To evaluate the diagnostic performance of blood-based SPOT-MAS test in symptomatic individuals, the investigators sought to launch a prospective multicenter study, named K-ACCELERATE.
- Conditions
- Cancer Colon, Cancer, Liver, Cancer, Lung, Cancer, Breast
- Trial name
- K-ACCELERATE (NCT06391749)
- Where
- Vietnam
- Volunteers
- 1,000 people
- Sponsor
- Gene Solutions
Cancer, Breast, Triple Negative Breast Cancer
VISION: Triple Negative Breast Cancer Sample and Clinical Data Acquisition Study
Background: Despite improvements in the treatment of Triple Negative Breast Cancer (TNBC), the cancer returns in half of the women and shockingly 40% are dead within 5 years of their initial cancer diagnosis.
- Conditions
- Cancer, Breast, Triple Negative Breast Cancer, Early-stage Breast Cancer
- Trial name
- NCT06409221
- Testing
- Non-interventional study, Observational only
- Where
- United Kingdom
- Volunteers
- 200 people
- Sponsor
- Concr
Healthy
Desaturation Validation of INVSENSOR00036
This study is designed to evaluate the trending accuracy of a noninvasive regional oximetry measurement of somatic oxygen saturation.
- Trial name
- NCT04002960
- Testing
- INVSENSOR00036
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Breast Cancer
Validation Study Using the GeneSearch BLN Assay to Test Sentinel Lymph Nodes From Patients With Breast Cancer
The purpose of this trial is to show adequate assay performance on clinical samples tested in real time at the clinical site.
- Trial name
- NCT00551278
- Testing
- GeneSearch™ Breast Lymph Node (BLN) Assay
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Janssen Diagnostics, LLC
COVID-19
Clinical Validation of Breath Analyser Tests for Diagnosis of COVID-19.
The Sponsor has developed a rapid screening tool intended to determine if the subject tested is COVID-19-free (Negative to COVID-19).
- Trial name
- NCT05094674
- Testing
- Breath Sample analysis
- Where
- United Kingdom
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Tera Group
Pathology
Feature Detection Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
The objective of this study is to evaluate the repeatability and reproducibility of detection of histological features using whole slide imaging
- Trial name
- NCT03992768
- Testing
- Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
- Where
- 3 sites in United States
- Volunteers
- 540 people
- Sponsor
- Hamamatsu Photonics K.K.
Retinitis Pigmentosa, Retinal Dystrophy
Observational Study to Assess the Reliability and Validity of the MLYMT and MLSDT
This is a prospective Multi-Center Observational Study to assess the reliability and validity of the Multi-Luminance Y-Mobility Test (MLYMT) and Multi-Luminance Shape Discrimination Study (MLSDT) Main Outcome Measures: (i)…
- Trial name
- NCT05820100
- Testing
- Observational
- Where
- 8 sites in United States, Puerto Rico
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Nanoscope Therapeutics Inc.
Aging, Aging Well
100-Year Human Aging Study
The 100-Year Human Aging Study is a prospective, pragmatic, observational trial enrolling participants across fixed clinical sites, mobile clinical sites, and an online participation pathway (current and future) to undergo…
- Conditions
- Aging, Aging Well, All-Cause Mortality, Mortality
- Trial name
- NCT07563777
- Testing
- Comprehensive Multi-System Clinical Screening
- Where
- United States
- Volunteers
- 1,000,000 people, healthy volunteers welcome
- Sponsor
- Longevity Metrics, Inc.
Movement Disorders, Parkinson Disease
Personal KinetiGraph® Clinical Validation Study
The purpose of this study is to clinically validate new measures of the Personal KinetiGraph® (PKG®).
- Trial name
- NCT05251701
- Testing
- Personal KinetiGraph® (PKG®) System
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Global Kinetics Corporation
Multiple Sclerosis
Validation of DigiCog and Konectom Tools to Support Digitalized Clinical Assessment in Multiple Sclerosis
The primary objective of this study is to establish scores of Cognitive impairment (CI) of the 3 DigiCog [Brief Computerized Cognitive Assessment for Multiple Sclerosis (BCCAMS) app] tests [Computerized Speed Cognitive Test…
- Trial name
- DigiToms (NCT04756700)
- Testing
- DigiCog (BCCAMS app), Konectom Application
- Where
- France
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- Biogen
Hypoxia
Optical Brain Pulse Monitor: Validation Of Cerebral Oximetry Monitoring (OBPM:VOCOM) Study.
The purpose of this study is to calibrate and validate a cerebral oximeter product from Cyban Pty. Ltd. The study will involve comparing cerebral oximeter signals against reference arterial and jugular bulb blood gas measures.
- Trial name
- OBPM:VOCOM (NCT06657820)
- Testing
- Hypoxia in healthy individuals, Cerebral Oximetry, Blood Gas Sampling
- Volunteers
- healthy volunteers welcome
- Sponsor
- Elliot Teo
Cervical Intraepithelial Neoplasia Grade 2/3, Neoplasm Cervix
Evaluation of in Vitro Devices on Self-collected Vaginal Swab and Urine Sample for Testing of Human Papilloma Virus
The European VALHUDES study is a Clinical Performance /Diagnostic Test Accuracy Study that aims to evaluate whether HPV testing with new assays performed on self-samples, collected by means of a vaginal and a urine collection…
- Conditions
- Cervical Intraepithelial Neoplasia Grade 2/3, Neoplasm Cervix, Carcinoma in Situ, Carcinoma Cervix Uterine
- Trial name
- EU-VALHUDES (NCT04312737)
- Testing
- Self-Collecting Devices, In Vitro Diagnostic Assays
- Where
- 6 sites in Ireland, Italy and 1 more
- Volunteers
- 600 people
- Sponsor
- Hiantis Srl
Dehydration, Hypovolemia
Validation of a Wearable Bioimpedance Sensor for Hydration Monitoring
The purpose of the project is to validate the performance of a wearable bioimpedance sensor (Re:Balans®) for monitoring hydration status.
- Trial name
- VAMOS (NCT07655401)
- Testing
- Bioimpedance sensor
- Where
- Norway
- Volunteers
- 60 people
- Sponsor
- Mode Sensors AS
Human Papillomavirus (HPV), Cervical Intraepithelial Neoplasia
Validation of a Lab-free Low-cost Screening Test for Prevention of Cervical Cancer
The purpose of this study is to validate Automated Visual Evaluation (AVE), specifically the CINFinder version developed by DL Analytics, a point-of-care screening and triage diagnostic tool for cervical cancer based on the…
- Conditions
- Human Papillomavirus (HPV), Cervical Intraepithelial Neoplasia, Uterine Cervical Neoplasms, Cervical Cancers
- Trial name
- OPTICS (NCT06815939)
- Testing
- HPV Test, EVA System, Visual Inspection with Acetic Acid (VIA)
- Where
- El Salvador
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- DL Analytics
Sleep Disorder, Depressive; Behavioral Disorder
Analysis of Sleep Study Data to Assess Depressive Burden
This study evaluates the effectiveness of the MEB-001 device in assessing physiological parameters that provide a clinically significant depressive burden screener.
- Conditions
- Sleep Disorder, Depressive; Behavioral Disorder, Mood Disorders
- Trial name
- SADB (NCT04232267)
- Testing
- MEB-001
- Where
- 5 sites in United States
- Volunteers
- 329 people
- Sponsor
- Medibio Limited
Patients Receiving Rivaroxaban Treatment
Validation of Rivaroxaban Assay for US Registration
The objective of the study is to demonstrate the performances of the STA® - Rivaroxaban Calibrator and STA® - Rivaroxaban Control in combination with the STA® - Liquid Anti-Xa to determine the quantity of rivaroxaban in plasma…
- Trial name
- NCT02333929
- Testing
- STA- Rivaroxaban Calibrator&Control
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Diagnostica Stago
Nasal Valve Collapse
Validity Study of a Nasal Valve Implant
The purpose of this study is to determine if an implant material can be injected to repair nasal valve collapse.
- Trial name
- NCT00837525
- Testing
- nasal valve implant
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Nasoform, LLC
Blindness, Acquired
A Validation of the Functional Low-Vision Observer Rated Assessment (FLORA-20) for Profoundly Blind Individuals
This study aims to validate an observer-rated assessment titled "Functional Low-Vision Observer Rated Assessment (FLORA-20)", which comprises 20 functional vision tasks commonly performed in or around a blind individual's home…
- Trial name
- FLORA-20 (NCT04312763)
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Second Sight Medical Products