Clinical trials: Validation
SpO2 (Peripheral Oxygen Saturation) Measurement Validation, SpO2
SpO2 Infant and Pediatric Study
This study evaluates the pulse oximetry (SpO₂) sensor for clinical performance, form, and fit in hospitalized infants and children (28 days to 12 years).
- Trial name
- SpO2 Peds (NCT07615738)
- Testing
- SpO2 Sensor
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- GE Healthcare
Device Validation of In-vivo Performance
Trima Non-DEHP Leukoreduced Red Blood Cell In Vivo Recovery Study
This is an in vivo 24-hour in-vivo recovery study of leukoreduced red blood cells (RBCs) collected on the Trima Accel System using Non-DEHP disposable sets and stored for 42 days.
- Trial name
- NCT06602804
- Testing
- Trima Accel Auto RBC Collection
- Where
- 2 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Terumo BCT
Validation Study
Gait Metric Validation of the Cionic Neural Sleeve
The purpose of this study is to determine the validity of the Neural Sleeve gait metrics compared to gait parameters assessed with a Protokinetics Zeno pressure sensitive walkway.
- Trial name
- NCT06503354
- Testing
- Neural Sleeve and Zeno walkway
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Cionic, Inc.
Pulse Oximeter Validation
Evaluation of Accuracy of the Owlet OSS 3.0 Sensor in the Neonatal Population
The sponsor of this study, Owlet Baby Care, Inc., is comparing the accuracy of their pulse oximeter Sensor with the measurements of oxygen levels in newborns who are already being monitored with arterial blood samples.
- Trial name
- NCT06771206
- Testing
- Owlet pulse oximeter neonatal accuracy validation
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Owlet Baby Care, Inc.
Device Validation of In-vivo Performance
An In Vivo 24-Hour Recovery Study of Whole Blood by the Reveos System
This is an in vivo 24-hour recovery study of leukoreduced red blood cells (RBCs) after automated separation of whole blood by the Reveos Automated Blood Processing System and storage for 42 days.
- Trial name
- NCT05239455
- Testing
- Reveos® Automated Blood Processing System
- Where
- 2 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Terumo BCT
SpO2 (Peripheral Oxygen Saturation) Measurement Validation
Philps FAST2022 picoSAT Pulse Oximetry Desaturation Study
Validation study to compare the accuracy of non-invasive Philips SpO2 sensors in detecting blood oxygen levels compared to invasive methods requiring a blood draw and lab analysis.
- Trial name
- NCT05683366
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
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
Respiratory and Pulse Rate Accuracy Validation
Binah.ai Visual Vitals Application - Validation Study
The purpose of this study is to conduct a Respiratory and Pulse Rate accuracy validation comparing the Binah.ai Visual Vitals Application to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda), and a…
- Trial name
- NCT05539612
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Binah.ai LTD.
Validation Study
The Sunrise SpO2 and Pulse Rate Accuracy Validation Study
The purpose of this study is to evaluate the SpO2 accuracy performance of the Sunrise Sensor 2 placed at the tip of the chin during non-motion conditions over the range of 70-100% by comparison to SaO2 values determined from…
- Trial name
- S2-SOPRAV (NCT05386836)
- Testing
- Pulse oximeter validation population
- Where
- Belgium
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Sunrise
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
Delayed Union Fracture, CT-scan
A mRUS Validation Study for Nail-treated Fractures of Long Bones and a TUS Exploratory Study for Nail and Plate-treated Fractures of Long Bones
Early intervention attempts to shorten protracted delayed union (DU) or prevent non-union (NU) fractures are hampered by lack of validated quantitative assessment tools for bone fracture healing during normal and delayed healing…
- Conditions
- Delayed Union Fracture, CT-scan, X-Ray, Bone Fracture
- Trial name
- mRUSTUS (NCT03286270)
- Where
- 4 sites in Germany
- Volunteers
- 173 people
- Sponsor
- Bone Therapeutics S.A
Calibration and Validation of Analyte Testing System
A Human Clinical Study to Collect Calibration and Performance Data for the RBA-1 and KBS-1
The purpose of the Kaligia Biosciences KBS Systems 1.0(b) analyte monitoring device is to measure the blood analyte levels in patients.
- Trial name
- NCT04305938
- Testing
- Minimally invasive and non-invasive blood analyte measurement
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Kaligia Biosciences, LLC
Validation Studies
Real-Ear Measurement (REM) and Test Box System Integration Into Fitting Software
Integration of the REM-verification within the fitting workflow will enable the hearing care professional to easily run real ear measurements.
- Trial name
- NCT02555462
- Testing
- Real-Ear Measurement system integrated in hearing aid fitting software
- Where
- Switzerland
- Volunteers
- 205 people, healthy volunteers welcome
- Sponsor
- Phonak AG, Switzerland
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.
Validation, Dried Blood Spot
To Validate an Analytical Method to Measure Concentration of Tacrolimus in Blood Taken From Finger Pricks
The principal aim of this study is to define the relationship between tacrolimus concentrations determined from the finger prick DBS (Dry Blood Spot) method and those determined from blood samples collected by venepuncture in…
- Conditions
- Validation, Dried Blood Spot, Transplant Patients
- Trial name
- NCT02377609
- Testing
- Tacrolimus
- Where
- 6 sites in France, United Kingdom
- Volunteers
- 108 people
- Sponsor
- Astellas Pharma Europe Ltd.
Quantitative Validation for Ventricular SPECT Imaging
Validation of Quantitative Ventricular Function Imaging Single Photon Emission Tomography (Spect)Using the D-SPECT Cardiac Camera
The purpose of this study is to validate the use of DSPECT camera for the performance of quantitative spect ventricular function imaging by comparison to a validated procedure performed on standard nuclear cameras.
- Trial name
- NCT01296737
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Spectrum Dynamics