Clinical trials: Validity
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
Weight
Validation of the Mercy TAPE
In 'real-world' health care settings there exist a number of circumstances where the weight of a child is desirable or even necessary but unavailable.
- Trial name
- TAPE (NCT01507090)
- Testing
- Mercy TAPE
- Where
- 3 sites in United States
- Volunteers
- 642 people, healthy volunteers welcome
- Sponsor
- Susan Abdel-Rahman
Healthy
Validation of Brain Oxygenation Monitor
A cerebral oximeter is a device that uses light to measure the amount of oxygen within the brain. It is similar to the device that measures the level of oxygen in the tip of the finger, known as a pulse oximeter.
- Trial name
- NCT00815490
- Testing
- Desaturation
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Duke University
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
Substance Use Disorder
The Tobacco, Alcohol, Prescription Medication and Other Substances Tool
The purpose of the study is to develop and validate a questionnaire to screen and assess adult primary care patients for tobacco, alcohol, prescription drug, and drug use and problems related to their use.
- Trial name
- CTN0059 (NCT02110693)
- Testing
- Interviewer and tablet administration of the TAPS Tool
- Where
- 4 sites in United States
- Volunteers
- 2,057 people, healthy volunteers welcome
- Sponsor
- Friends Research Institute, Inc.
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
ELECTROENCEPHALOGRAPHIC VARIANT PATTERN 1 (Disorder)
Self Abrading Rapidly Applied Electrode Validation
The SARA (Self Abrading Rapidly Applied) electrode will speed EEG patient hookup by combining multiple steps that burden conventional EEG procedures into one.
- Trial name
- SARA (NCT02200523)
- Testing
- SARA electrode, Gold cup
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Cleveland Medical Devices Inc
Dementia, Alzheimer Disease
The Brain Health Study: A Pragmatic, Patient-Centered Trial
The eRADAR Brain Health Study is an embedded, pragmatic clinical trial to determine whether targeted screening for dementia using the eRADAR algorithm increases dementia detection within primary care compared to usual care.
- Trial name
- eRADAR (NCT05905796)
- Testing
- Brain Health Assessment
- Where
- 3 sites in United States
- Volunteers
- 1,261 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Healthy
Oxygen Reserve Index (ORi) Validation of INVSENSOR00025
ORi is a unitless index that could help clinicians with their assessments or normoxic and hyperoxic states by scaling the measured absorption information between 0.00 and 1.00.
- Trial name
- NCT03628898
- Testing
- INVSENSOR00025
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Cardiopulmonary Disease
Clinical Validation Study for Noninvasive Cardiopulmonary Management Device
The ADI At-Home CPM (Cardiopulmonary Management) System is a non-invasive device that measures and trends a variety of biological parameters.
- Trial name
- NCT04865640
- Testing
- Noninterventional and noninvasive
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Analog Device, Inc.
Visual Acuity
Design Validation of Toric Contact Lenses in Senofilcon A With a Blue-Blocking Chromophore
This will be a 4-visit, randomized, controlled, single-masked, bilateral wear, dispensing, 2-treatment, 2-sequence, 2-period crossover study.
- Trial name
- NCT05778786
- Testing
- Acuvue Oasys 1 Day for Astigmatism, TRA100/TRA200 series toric contact lens with HEVL-blocking chromophore
- Where
- 10 sites in United States
- Volunteers
- 188 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Vision Care, Inc.
Healthy
Clinical Validation for SpO2 Function of Masimo INVSENSOR00069
Assess the accuracy of INVSENSOR00069's peripheral oxygen saturation (SpO2) against contemporaneous measurement from arterial blood gas (ABG) analysis.
- Trial name
- NCT06120777
- Testing
- INVSENSOR00069
- Where
- United States
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Infiltration of Peripheral IV Therapy
ivWatch Model 400: Device Validation for Infiltrated Tissues
A single arm trial consisting of 70 adult volunteers to assess the safety and efficacy of the ivWatch Model 400 when observing infiltrated tissues at common sites for peripheral IV therapy.
- Trial name
- NCT02123745
- Testing
- The ivWatch Model 400
- Where
- United States
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- ivWatch, LLC
Refractive Errors, Astigmatism
Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye
Single-center, open-label, prospective study in healthy volunteers desiring refraction for correction of visual acuity to compare a handheld device supported by a mobile application with the phoropter and autorefractor.
- Trial name
- NCT03929588
- Testing
- Hand-held device supported by a mobile application, Phoropter, Autorefractor
- Where
- United States
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- EyeQue Corp.
Opioid Abuse, Prescription Drug Abuse (Not Dependent)
Validation of a Community Pharmacy-Based Prescription Drug Monitoring Program Risk Screening Tool
The goal of the study is to validate a Prescription Drug Monitoring Program-based opioid risk metric to discriminate between low, moderate, and high-risk opioid use disorder.
- Trial name
- PHARMSCREEN (NCT03936985)
- Where
- 2 sites in United States
- Volunteers
- 1,464 people, healthy volunteers welcome
- Sponsor
- University of Utah
Nutrition Assessment
Validity of an AI-based Program to Identify Foods and Estimate Food Portion Size
The purpose of this study is to test the accuracy of the Nutrition Artificial Intelligence in the Openfit app during meals in a controlled laboratory setting
- Trial name
- PortionSizeAI (NCT05343585)
- Testing
- PortionSize AI
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pennington Biomedical Research Center
Healthy
Desaturation Validation of INVSENSOR00028
This study is designed to measure the trending accuracy of a noninvasive regional oximetry measurement of somatic oxygen saturation. Two large sensors (adult sensors) will be placed on the subject's forehead.
- Trial name
- NCT03704636
- Testing
- INVSENSOR00028
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Gastroenteritis
Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults
The purpose of this trial is to obtain serum for proficiency testing to confirm assay validity is maintained following the dosing of adults with a pediatric dose of HIL-214.
- Trial name
- NCT05972733
- Testing
- HIL-214
- Where
- 2 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- HilleVax
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
Healthy
Oxygen Reserve Index (ORi) Expanded Data Set Validation of INVSENSOR00025
ORi is a unitless index that could help clinicians with their assessments or normoxic and hyperoxic states by scaling the measured absorption information between 0.00 and 1.00.
- Trial name
- NCT04079816
- Testing
- INVSENSOR00025
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation