Clinical trials: Validation
Dietary Habits
PortionSize Study 2 Free-Living Evaluation
The objective is to test the accuracy of the PortionSize™ app and the MyFitnessPal© app at measuring energy and nutrient intake in free-living conditions.
- Trial name
- NCT05166226
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Pennington Biomedical Research Center
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.
Surgery
Validation of Noninvasive Hemoglobin, Comparison of PVI to Standard Methods, and Validation of Clinical Efficacy of ORI
The study goal is to establish the correlation of hemoglobin values determined by the noninvasive pulse oximetry-determined hemoglobin (SpHb) system with hemoglobin as measured by other validated devices.
- Trial name
- NCT02841397
- Testing
- Masimo Pulse CO-Oximeter
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Masimo Corporation
System Validation
Wetness Sensing System
The investigational product to be evaluated in this study is FitRight® ConnectTM Wetness Sensing System which includes: the FitRight® ConnectTM Pod, the FitRight® ConnectTM App, the FitRight® ConnectTM charger/adapter and the…
- Trial name
- NCT05454813
- Testing
- Wetness Sensing System Validation
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Medline Industries
Coronary Artery Disease, Coronary Stenosis
FUnctional diagnoSIs of corONary Stenosis (FUSION)
The purpose of the FUSION study is to validate the diagnostic performance of Virtual Flow Reserve (VFR) by comparing it against a reference standard, fractional flow reserve (FFR).
- Trial name
- FUSION (NCT04356027)
- Testing
- ICA (Invasive Coronary Angiography), OCT, FFR
- Where
- 28 sites in United States
- Volunteers
- 312 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Electrocardiogram Clinical Validation Study
The purpose of the study is to confirm the software's ability to create a Lead-1 electrocardiogram (ECG) that is clinically equivalent to a reference device.
- Trial name
- NCT03492554
- Testing
- 1-Lead ECG, 12-Lead ECG
- Where
- 5 sites in United States
- Volunteers
- 602 people, healthy volunteers welcome
- Sponsor
- Apple Inc.
Plantar Fasciitis, Chronic, Heel Pain Syndrome
Validation of a Novel Foot Offloading Device
Pressure offloading is often considered the most crucial aspect in healing after a foot injury. The investigators have devised a novel foot offloading device (PopSole™) which will allow for customization of the area where there…
- Conditions
- Plantar Fasciitis, Chronic, Heel Pain Syndrome, Fat Pad Syndrome
- Trial name
- PopSole2 (NCT04378270)
- Testing
- PopSole™ Offloading Device
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Jeffrey A. Gusenoff, MD
Healthy
Nonin 4 Wavelength Cerebral Oximeter Study
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
- Nonin4 (NCT01762722)
- Testing
- Reduction of inspired oxygen
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Duke University
Multiple Sclerosis
Validity and Reliability of the 6-minute Walk Test Over a Distance of 6 Metres in People With Multiple Sclerosis
The objective of this study is to validate a different version of the 6 minutes Walk Test (6minWT), the 6minWT on 6 meters, instead of the 30 meters.
- Trial name
- VR6minWT6 (NCT04228328)
- Testing
- The 6-minutes Walk Test
- Where
- Switzerland
- Volunteers
- 21 people
- Sponsor
- Haute Ecole de Santé Vaud
Healthy, Atrial Fibrillation
Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057
The objective of this study is to validate the performance of the electrocardiogram (ECG) function of the Masimo INVSENSOR00057 against contemporaneous measurements
- Trial name
- NCT06071754
- Testing
- Masimo INVSENSOR00057
- Where
- 4 sites in United States
- Volunteers
- 365 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Sleep Apnea Syndromes, Sleep Disorder
WatchPAT Device Validation Study Compared to Polysomnography
Validation study of a novel sleep Device compared to a traditional sleep study.
- Conditions
- Sleep Apnea Syndromes, Sleep Disorder, Sleep
- Trial name
- WPAT (NCT03188718)
- Testing
- WatchPAT Intervention
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Type2 Diabetes
Validation of Machine Learning Based Personalized Nutrition Algorithm to Reduce Postprandial Glycemic Excursions Among North American Individuals With Newly Diagnosed Type 2 Diabetes
This is an initial validation study of the Personal Nutrition Project (PNP) algorithm in a North American population with recently diagnosed Type 2 Diabetes (T2D).
- Trial name
- NCT03053518
- Testing
- Abbott Freestyle Libre Pro, LifeStyle
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- NYU Langone Health
Myopia, Astigmatism
Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses
The study hypothesis is there is no difference in the clinical performance between the test and control lenses, in particular in lens stability, toric mislocation, comfort ratings and anterior segment ocular health findings.
- Trial name
- NCT02185105
- Testing
- comfilcon A MTO, comfilcon A
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- CooperVision, Inc.
Obstructive Sleep Apnea
Validation of the ApneaLink Sleep Screener for Obstructive Sleep Apnea (OSA)
The primary endpoints for this study are that the AL validation will 1) achieve a sensitivity of greater than 80% for AHI values greater than or equal to 15, and 2) demonstrate a correlation coefficient of r=0.75 indicating…
- Trial name
- NCT00354614
- Testing
- ApneaLink Sleep Screener
- Where
- United States
- Volunteers
- 81 people
- Sponsor
- ResMed
Tobacco Dependence
UW Withdraw From Tobacco Study
It is of considerable scientific and clinical importance to assess tobacco withdrawal accurately since withdrawal severity is highly determinant of smoking cessation success.
- Trial name
- NCT04969198
- Testing
- Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge)
- Where
- United States
- Volunteers
- 232 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Sleep Disordered Breathing
User Preference/Validation Evaluation of the New Philips Respironics Positive Airway Pressure Application
This pilot study is intended to evaluate the acceptance and performance of the DreamMapper application and the Therapist Assist educational tool in naïve patients with Obstructive Sleep Apnea who have been prescribed Positive…
- Trial name
- NCT03748264
- Testing
- Standard of Care, DreamMapper Application, DreamMapper Application with Therapist Assist
- Where
- 5 sites in United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Philips Respironics
Alzheimer's Disease
[11C]MK-6884 Positron Emission Tomography (PET) Tracer Validation Trial (MK-6884-001)
The purpose of this open-label, 3-part study is to investigate the safety and efficacy of [11C]MK-6884 as a positron emission tomography (PET) imaging agent for quantifying muscarinic 4 (M4) positive allosteric modulator (PAM)…
- Trial name
- NCT02621606
- Testing
- [11C]MK-6884
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Atopic Dermatitis
Validation of the Short-term Antimicrobial Action of Transplanted Bacteria
Unlike healthy control skin, the skin of patients with atopic dermatitis (AD) is frequently colonized by Staphylococcus aureus (S. aureus), putting these patients at increased risk of S. aureus skin infections.
- Trial name
- NCT01959113
- Testing
- Autologous Microbiome Transplant
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of California, San Diego