Clinical trials: Validity
Non-muscle Invasive Bladder Cancer
Validation of a Urine-based Assay With Genomic Markers for Predicting Recurrence for Non-muscle Invasive Bladder Cancer
A study to validate, in a prospective manner, the ability of the predefined Genomic Health bladder cancer assay to detect recurrence in patients undergoing surveillance for non-muscle invasive bladder cancer.
- Trial name
- NCT02969109
- Where
- United States
- Volunteers
- 417 people
- Sponsor
- Genomic Health®, Inc.
Influenza Human
Clinical Validation of the Point-of-Care MSD Influenza Test
The primary objective of this study is to evaluate the performance of the MSD® Influenza Test in detecting influenza A and influenza B in subjects presenting with influenza-like-illness (ILI).
- Trial name
- NCT00863343
- Testing
- Public Health Notification
- Where
- 3 sites in United States
- Volunteers
- 391 people
- Sponsor
- Meso Scale Diagnostics, LLC.
Health Volunteer Validation Study
Vital Signs Validation Study of the μ-Cor System (ViVUS Validation)
This study has the following objective: To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR), Respiration Rate (RR), Posture and Activity in healthy human subjects.
- Trial name
- ViVUS (NCT02975050)
- Testing
- Location
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Zoll Medical Corporation
Blood Pressure Measurement
Philips Inflationary-Based Non-Invasive Blood Pressure Validation Study
The main purpose of this study is to assess the equivalence between blood pressure measurements obtained using the Philips iNIBP system and those determined by the auscultatory reference method.
- Trial name
- iNIBP (NCT07901608)
- Testing
- Blood Pressure Measurement
- Where
- United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
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.
Healthy
Desaturation Validation of INVSENSOR00039
This study is designed to compare the accuracy of a noninvasive measurement of oxygen saturation compared to reference values obtained by a laboratory blood gas analyzer.
- Trial name
- NCT04112784
- Testing
- INVSENSOR00039
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
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
Anemia
Spot-Check Noninvasive Pulse CO-Oximeter Validation
In this study, the accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.
- Trial name
- NCT02782806
- Testing
- Masimo Rad-67 Pulse Oximeter
- Where
- United States
- Volunteers
- 368 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Treatment Resistant Depression (TRD)
Ketamine Biomarker Validation
An EEG-based biomarker will be developed for the effects of ketamine infusion in patients with Depression. The effects of ketamine infusion on Depression symptoms and EEG signals will be analyzed.
- Trial name
- NCT07307768
- Testing
- Ketamine (0.25 mg/kg), Ketamine (0.5 mg/kg), Ketamine (0.75 mg/kg)
- Where
- United States
- Sponsor
- Soterix Medical
Lung Cancer
Clinical Validation of InferRead Lung CT.AI
Lung cancer is the second most common cause of cancer-related death in men and women. Early pulmonary nodule screening is an effective means to prevent lung cancer, which is no less important than the diagnosis and treatment of…
- Trial name
- NCT04119960
- Testing
- Aided read with InferRead Lung CT.AI
- Where
- United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Infervision
Major Depressive Disorder (MDD)
Validation of Accexible as a Tool for Screening and Monitoring Depression.
Major depressive disorder (MDD) is a chronic disease with a prevalence around 8-12% and is considered one of the most debilitating disease worldwide.
- Trial name
- NCT06044818
- Testing
- Accexible
- Where
- Spain
- Volunteers
- 166 people, healthy volunteers welcome
- Sponsor
- Accexible
Vital Sign Evaluation
Respiratory Rate Validation Study - Mindset Medical Informed Vital Core Application
Evaluating the Accuracy of a Web-Based Application - Vital Sign Measurement Platform. This single-arm cohort, open-label study is designed to evaluate the accuracy of a web-based application designed for measurements of vital…
- Trial name
- NCT06508047
- Testing
- Informed Vital Core App
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Mindset Medical
Hypertension
Withings Hypertension Notification Retrospective Study
This retrospective, non-interventional clinical investigation evaluates the diagnostic performance of the Withings Hypertension Notification Feature (HTNF), a software-only medical device (SaMD) that analyzes demographic…
- Trial name
- HTNF (NCT07631715)
- Testing
- Withings Blood Pressure Monitor (reference), Withings Hypertension Notification Feature (HTNF)
- Where
- France
- Volunteers
- 2,500 people, healthy volunteers welcome
- Sponsor
- Withings
Hypertension
Lifelight Non-Invasive Blood Pressure and Heart Rate Validation Study
Lifelight is a novel, calibration-free, software-only medical device that contactlessly measures pulse rate and blood pressure by measuring remote photoplethysmography (rPPG) signals of a patient's face using a standard…
- Trial name
- NCT06535152
- Testing
- Lifelight, Manual sphygmomanometer
- Where
- United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Xim Limited
Colorectal Cancer
Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"
The primary objective of this study is to assess the sensitivity for colorectal cancer (CRC) and specificity of the mt-sDNA 2.0 test.
- Trial name
- NCT04144738
- Testing
- mt-sDNA 2.0 screening test, FIT test, Colonoscopy
- Where
- 195 sites in United States
- Volunteers
- 26,758 people, healthy volunteers welcome
- Sponsor
- Exact Sciences Corporation
Breast Cancer
Case Collection Study for Collecting Images for the Development and Validation of Computer Aided Detection Software
The study objective is to assess the performance of the MammoDetector Pro to correctly mark biopsy-proven breast cancers imaged on the Siemens Mammomat Novation FFDM system compared to conventional film-screen mammography.
- Trial name
- NCT00756834
- Testing
- Screening
- Where
- United States
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- Siemens Medical Solutions
Pressure Ulcer, Pressure Injury
Usability Validation of Patient Monitoring Device for Pressure Injury Prevention and Fall Detection
This study describes a procedure to collect a subject's position, movement, physiological data and usability information using Masimo's investigational device.
- Conditions
- Pressure Ulcer, Pressure Injury, Falls Injury
- Trial name
- NCT03121144
- Testing
- Masimo Centroid System
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Masimo Corporation
Influenza A, Influenza B
Validation of the Ellume® Respirio Flu Test and the Ellume® eLab 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 and the eLab Flu Test in detecting Influenza A as compared to the gold standard for detection, Reverse Transcriptase…
- Trial name
- NCT02767414
- Testing
- Respirio Flu Test, eLab Flu Test, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
- Where
- 7 sites in Australia
- Volunteers
- 1,500 people
- Sponsor
- Ellume Pty Ltd
Obstructive Sleep Apnea
Validation of a Simplified MATRx Plus
Sleep apnea (OSA) is a condition in which the air passage in the throat closes or partly closes during sleep and repeatedly interrupts breathing.
- Trial name
- NCT03812692
- Testing
- MATRx plus
- Where
- Canada
- Volunteers
- 59 people
- Sponsor
- Zephyr Sleep Technologies
Healthy
Oxygen Reserve Index Validation for RD Lite Sensors
Oxygen Reserve Index (ORI) is a parameter that provides information on arterial partial pressure of oxygen (PaO2). In this study, the PaO2 is varied by controlling the concentration of oxygen the study volunteer breathes.
- Trial name
- NCT03128892
- Testing
- Oxygen Reserve Index - RD Lite Sensors
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation