Clinical trials: Accuracy
Hypoxia
Polso SpO2 Accuracy Validation Study
The purpose of this study is to validate the oxygen saturation (SpO2) accuracy of the Polso Monitoring System during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by…
- Trial name
- NCT03735329
- Testing
- Diagnostic test of SPO2
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- ChroniSense Medical Ltd.
Term Labour
Accuracy and Reliability of Novii: Fetal Heart Rate (FHR), Maternal Heart Rate (MHR) and Uterine Contraction (UA) Compared With Doppler, Scalp Fetal Scalp Electrode (FSE), Tocodynamometer (TOCO) and Intra Uterine Pressure Catheter (IUPC)
Accuracy and Reliability of the Novii device (fetal heart rate, maternal heart rate and uterine activity) compared with Food and Drug Administration (FDA) approved techniques
- Trial name
- NCT03409146
- Testing
- Monica Novii Wireless Patch System
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- GE Healthcare
Hypoxia
Induced Hypoxia Study for Validation of SpO2 Accuracy
Validate Non-Motion SpO2 Accuracy from 70%-100% of various pulse oximeter/ sensor combinations and various OEM pulse oximeter modules and sensor combinations during induced hypoxia (desaturation).
- Trial name
- NCT00788983
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Nonin Medical, Inc
Intracranial Neoplasm
Accuracy of Robotically Assisted Cranial Biopsies
This is an observational post-market study determining biopsy accuracy in a clinical environment using Cirq® Robotic Alignment Module Cranial.
- Trial name
- NCT05891002
- Testing
- Cirq® Robotic Alignment Module Cranial
- Where
- France
- Volunteers
- 4 people
- Sponsor
- Brainlab AG
Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
Diagnostic Accuracy Of Seismocardiography for Coronary Artery Disease
This study aims to evaluate a new, non-invasive method for detecting coronary artery disease (CAD) using seismocardiography (SCG) and gyrocardiography (GCG).
- Trial name
- HF-CAD (NCT06880120)
- Testing
- Seismocardiography (SCG) and Gyrocardiography (GCG) Diagnostic Testing
- Where
- Uzbekistan
- Volunteers
- 1,534 people, healthy volunteers welcome
- Sponsor
- Heart Force Medical Inc.
Neuropathy
Withings Study to Analyse the Accuracy of Screening Small Fiver Neuropathy With a Bathroom Scale
The aim of this study is to evaluate the diagnostic performance of Withings WBS08 to screen small fiber neuropathy.
- Trial name
- WISUDO (NCT05178459)
- Testing
- Neuropathy measurement
- Where
- 4 sites in France
- Volunteers
- 177 people
- Sponsor
- Withings
Body Fat
Clinical Study About Fat Measurement on Multifunction Keito by Comparison Versus Its Predicate K014009
The researchers believe that the multifunction Keito devices shares with TANITA TBF-300 (K014009) the same efficacy on the body fat measurement.
- Trial name
- NCT01360619
- Where
- Spain
- Volunteers
- 177 people, healthy volunteers welcome
- Sponsor
- Aguiflai Iberica, S.L.
Albuminuria, Chronic Kidney Diseases
Evaluation of the Accuracy and Usability of the Minuteful - Kidney Urine Analysis Test System in the Lay User Hands
The purpose of this study was to collect additional performance and clinical data on the Minuteful - Kidney test device (previously "ACR | U.S. Urine Analysis Test System"), following the original data collection (NCT04626271).
- Conditions
- Albuminuria, Chronic Kidney Diseases, Diabetes, Hypertension
- Trial name
- NCT05838872
- Testing
- Minuteful - Kidney Urine Analysis Test System
- Where
- United States
- Volunteers
- 216 people
- Sponsor
- Healthy.io Ltd.
Diabetes Mellitus, Diabetes Mellitus, Type 1
Enhance Study: Evaluation of Accuracy and Safety of the Eversense CGM System With Enhanced Features
A Prospective, Multicenter Evaluation of Accuracy and Safety of the Eversense CGM System with Enhanced Features. The purpose of this clinical investigation is to evaluate the accuracy of the Eversense 524 Continuous Glucose…
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- NCT05131139
- Testing
- Continuous Glucose Monitoring System
- Where
- 4 sites in United States
- Volunteers
- 350 people
- Sponsor
- Senseonics, Inc.
Respiratory Rate Accuracy Test, Capnography
Clinical Validation of a Novel, Accelerometer Based, Continuous Respiratory Rate Sensor
Comparing a wireless accelerometer-based sensor that continuously measure breathing rate with the gold standard capnography. The aim is to evaluate if both methods are equivalent.
- Conditions
- Respiratory Rate Accuracy Test, Capnography, Wireless Vital Signs Monitoring System, Respiratory Rate
- Trial name
- NCT06911541
- Testing
- Wireless respiratory rate monitor
- Where
- Norway
- Volunteers
- 29 people
- Sponsor
- Eupnea AS
Refractive Errors
Investigation of the Accuracy of an Automated Refractor to Provide Well-tolerated Eyeglass Prescriptions
At the New England College of Optometry in Boston, MA, subjects ages 18-65 who have received or are receiving treatment for refractive error who choose to enroll in the study will be evaluated using subjective refraction and…
- Trial name
- NCT06883032
- Testing
- AR Eyeglasses first, SR Eyeglasses second, SR Eyeglasses first, AR Eyeglasses second
- Where
- United States
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- PlenOptika, Inc.
Oxygen Saturation
Accuracy Performance Verification of the INVOS™ PM7100 System in Adults
Prospective, observational, post-market, verification study to ensure compliance to the ISO 80601-2-85:2021 standard
- Trial name
- NCT06581835
- Testing
- Observational
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Bacterial Infections
Development and Accuracy Evaluation of Gram Staining Analysis AI
The investigators use Gram-stained specimens provided from clinical settings to develop and evaluate the accuracy of Gram staining analysis AI
- Trial name
- NCT06377592
- Testing
- Sample collection without intervention
- Where
- Japan
- Volunteers
- 18,000 people
- Sponsor
- GramEye
Hydrocephalus
ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients
The purpose of this study is to compare the accuracy of ShuntCheck (SC) and ShuntCheck plus Micro-Pumper (SC+MP) to radionuclide shunt patency testing (SPS) in evaluating shunt function in patients with adult hydrocephalus (AH)…
- Trial name
- SCNPH (NCT01323764)
- Testing
- ShuntCheck test
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- NeuroDx Development
Presence of High Intracranial Pressure
An Evaluation of Non-invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an External Ventricular Drainage (EVD) Device
Invasive intracranial pressure (ICP) monitoring is highly effective, but involves risks. HS-1000 measures ICP non-invasively by assessing the acoustic properties of the patient's head.
- Trial name
- NCT02284217
- Testing
- EVD
- Where
- 7 sites in United States, Germany
- Volunteers
- 100 people
- Sponsor
- HeadSense Medical
Diabetes, Diabetes Mellitus, Type 2
Reliability of Dosing With NovoLog® Mix 70/30 FlexPen® Compared With Vial and Syringe
This trial is conducted in the United States of America (USA). The aim of this trial is to compare desired (target) with actual target amounts of insulin dispensed using NovoLog® Mix 70/30 FlexPen® and vial and syringe in…
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Delivery Systems
- Trial name
- NCT00127296
- Testing
- FlexPen®, vial and syringe
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Novo Nordisk A/S
Colonic Polyp
Pivotal Study of the CapsoCam Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference
This study will evaluate the safety and effectiveness of the CapsoCam Colon (CV-3) endoscope system for the detection of colonic polyps.
- Trial name
- NCT04607746
- Testing
- Capsule Endoscope
- Where
- 23 sites in United States
- Volunteers
- 1,337 people
- Sponsor
- Capso Vision, Inc.
Clotting Disorders
Study to Determine the Accuracy of Prothrombin Time of Warfarinised Blood
The purpose of this study is to measure prothrombin time (PT) expressed in International Normalised Ratio (INR) units in persons receiving coumadin (warfarin) treatment on an experimental device and a commercially available…
- Trial name
- NCT01375725
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Universal Biosensors Pty Ltd
Healthy Volunteer
Accuracy of Respiree Pulse Oximeters With Profound Hypoxia
The aim of this project is to test the accuracy of pulse oximeters during mild, moderate and severe hypoxia. This is done by comparing the reading of the pulse oximeter during brief, steady state hypoxia with a gold-standard…
- Trial name
- SpO2 (NCT07785050)
- Testing
- Respiree SpO2
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Respiree Pte Ltd
Cardiac Output
Accurate Measurement of Cardiac Output Using the Ultrasound Dilution Technique
Accurate cardiac output determination is a commonly used and important index of myocardial performance. The thermodilution method using a pulmonary artery catheter is the most common approach to cardiac output determination…
- Trial name
- BCM (NCT00851422)
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Transonic Systems Inc.