Clinical trials: Validation
Oxygen Deficiency
Validation of Next Generation Cerebral and Tissue Oximeter
This is a validation study of a near-infrared spectroscopy (NIRS) device designed to measure the cerebral tissue oxygen saturation.
- Trial name
- NCT03128372
- Testing
- Desaturation
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Infiltration of Peripheral IV Therapy
ivWatch Sensor: Device Validation for Infiltrated Tissues
A single arm trial consisting of 98 adult volunteers to assess the safety and efficacy of ivWatch sensors when observing infiltrated tissues at common sites for peripheral IV therapy.
- Trial name
- NCT04064229
- Testing
- ivWatch Model 400 with SmartTouch Sensor, ivWatch Model 400 with Fiber Optic Sensor
- Where
- United States
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- ivWatch, LLC
Pathology
Instrument Precision Study for Validation of Philips Dx
The objective of this study is to evaluate precision of the Philips Dx system.
- Trial name
- NCT02699970
- Where
- United States
- Volunteers
- 399 people
- Sponsor
- Philips Digital & Computational Pathology
Autism Spectrum Disorder
Cognoa ASD Diagnosis Aid Validation Study
The primary objective of this study is to collect data to ascertain the Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of the current version of the Cognoa diagnostic device.
- Trial name
- NCT04151290
- Testing
- Cognoa ASD diagnostic device
- Where
- 16 sites in United States
- Volunteers
- 711 people
- Sponsor
- Cognoa, Inc.
Fluid Retention Tissue
Measuring Thoracic Impedance in Hemodialysis Patients With the u-Cor Monitoring System
The purpose of this study is to measure the fluid changes in the body using a device called the µ-Cor System, an investigational device.
- Trial name
- MaTcH (NCT03072732)
- Testing
- u-Cor System, ZOE Fluid Status Monitor
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Zoll Medical Corporation
Onychomycosis
Human Factors Testing for OTC Use of the Erchonia® LunulaLaser
Human factors validation testing to assess the intended user's ability to correctly, safely, and effectively set-up, activate and operate the LunulaLaser™ OTC, to administer a treatment to a suitably qualified client, and to…
- Trial name
- NCT05626270
- Testing
- LunulaLaser OTC
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Erchonia Corporation
Vital Sign Evaluation
Clinical Validation of Non-Contact Vital Signs
Vital signs are critically important to modern emergency medical care. These metrics (heart rate (HR), respiratory rate (RR), blood pressure, temperature, and pulse oximetry) have been shown to predict a patient's morbidity…
- Trial name
- NCT07362641
- Testing
- SmartSpectra Vital Signs Monitor measurement
- Where
- United States
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Presage Technologies, Inc.
Fever
Calibration and Validation of the Masimo Temperature Device in Febrile Patients
The goal of this clinical trial is to test the performance of the Masimo noninvasive temperature device in patients with fever. The main question it aims to answer is whether the Masimo temperature device is comparable to…
- Trial name
- NCT05674344
- Testing
- Masimo Temperature device
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- Masimo Corporation
Cardiovascular Diseases, Blood Pressure
VicorderCS NIBP Validation Study to Review The Ability to Capture Blood Pressure Measurements
80 Beats Medical introduces the VicorderCS, the next generation of our Vicorder technology designed to manage hypertension and cardiovascular risks.
- Conditions
- Cardiovascular Diseases, Blood Pressure, Hypertension
- Trial name
- NCT06560034
- Testing
- VicorderCS
- Where
- United States
- Volunteers
- 86 people
- Sponsor
- 80 Beats Medical
Healthy
Oxygen Reserve Index (ORi) Expanded Data Set Validation of INVSENSOR00029
ORi is a unitless index that could help clinicians with their assessments of normoxic and hyperoxic states by scaling the measured absorption information between 0.00 and 1.00.
- Trial name
- NCT04079842
- Testing
- INVSENSOR00029
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Coronary Artery Disease
Validation of a Vital Signs Monitoring Wristband
Today, continuous monitoring of vital signs remains a challenge since it generally requires the patient to be connected to multiple wired sensors, which restricts patient mobility in the intra-mural setting and complicates home…
- Trial name
- MULTI-VITAL (NCT05566886)
- Testing
- Continuous measurement of photoplethysmography at the wrist
- Where
- Netherlands
- Volunteers
- 100 people
- Sponsor
- Corsano Health B.V.
Sleep Apnea, Obstructive, Sleep Apnea, Central
DreamKit Respiratory Effort Signal Validation
This study has been developed in order to demonstrate the validity of the DreamKit respiratory effort signal.
- Trial name
- NCT04926077
- Testing
- DreamKit
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Clinical Indication for Brain MRI, Healthy Volunteers
Comparative Study of Conventional MR Images With Synthetically Reconstructed MR Images of the Brain
This study is being conducted for evaluation of 3D Synthetic MRI (SyMRI 15, 3D) for neuroimaging,
- Trial name
- NCT05425927
- Testing
- SyMRI 15 (3D)
- Where
- 6 sites in United States
- Volunteers
- 189 people, healthy volunteers welcome
- Sponsor
- SyntheticMR
Sleep Apnea, Obstructive
Validation of ApneaLink Air Home Sleep Testing in the Diagnosis of Obstructive Sleep Apnea in Adolescent Children
The feasibility and the validity of the ApneaLink Air home sleep testing (HST) device will be tested in adolescent children. The ApneaLink Air HST device is cleared for the diagnosis of obstructive sleep apnea (OSA) in adults..
- Trial name
- NCT03748771
- Testing
- ApneaLink Air
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- ResMed
Tinnitus
Efficacy of the Erchonia Corporation THL™ for Providing Relief of Tinnitus Symptoms
The purpose of this clinical study is to determine the effectiveness of the Erchonia® THL™, manufactured by Erchonia Corporation (the Company), for prescription home use in providing relief of tinnitus symptoms when used by…
- Trial name
- NCT05374421
- Testing
- Erchonia® THL™
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Erchonia Corporation
Gout
Validation Study of Physical Measurement of Tophi
The purpose of this study is to determine the inter- and intra-rater reproducibility of direct physical measurement of tophus nodules in subjects with gout.
- Trial name
- NCT00175006
- Testing
- Measurement of Tophi to validate procedure
- Volunteers
- 13 people
- Sponsor
- Takeda
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
Cosmetic Appearance
Evaluation of the Cosmetic Performance of AIR OPTIX® COLORS
The purpose of this study was to evaluate the cosmetic performance of AIR OPTIX® COLORS contact lenses compared to FRESHLOOK® COLORBLENDS contact lenses in habitual FRESHLOOK® COLORBLENDS contact lens wearers.
- Trial name
- NCT01398787
- Testing
- Lotrafilcon B contact lens with color, Phemfilcon A contact lens with color
- Volunteers
- 198 people, healthy volunteers welcome
- Sponsor
- CIBA VISION
Norovirus, Healthy Participants
Serologic Assay Validation, Proficiency Testing, Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine
The purpose of this study is to collect serum samples to evaluate serologic assays and to establish proficiency panels for serologic assays used for assessment of post vaccination immune response after intramuscular (IM)…
- Trial name
- NCT02475278
- Testing
- NoV GI.1/GII.4 Bivalent VLP Vaccine
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Takeda
Alzheimer's Disease, Amnestic Mild Cognitive Impairment
[18F]MK-6240 Positron Emission Tomography (PET) Tracer First-in-Human Validation Study (MK-6240-001)
This 2-part, open-label study was designed to investigate the safety, tolerability, and efficacy of [18F]MK-6240, a Positron Emission Tomography (PET) imaging agent, for the quantification of neurofibrillary tangle (NFT)…
- Trial name
- NCT02562989
- Testing
- [18F]MK-6240, ~185 MBq, [18F]MK-6240, ~160 MBq
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC