Clinical trials: Accuracy
Device Latency
Substudy 'B' of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)
The purpose of this study is to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.
- Trial name
- OSMITTER (NCT02404532)
- Testing
- MIND1 System
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Obesity
Evaluation of the Accuracy of a Computer Vision-based Tool for Assessment of Total Body Fat Percentage
This research study is designed to validate the precision and accuracy of body measurement and composition results from a novel 2D imaging device that operates through a smart-phone application.
- Trial name
- MEASURE (NCT04854421)
- Testing
- VBC
- Where
- 2 sites in United States
- Volunteers
- 138 people, healthy volunteers welcome
- Sponsor
- Pennington Biomedical Research Center
Breast Cancer
Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer
The purpose of this pilot is to provide credible performance estimate information in order to conduct a subsequent pivotal reader study.
- Trial name
- NCT03491917
- Testing
- DBT plus S-View, FFDM alone
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, Inc.
Healthy
Accuracy of Commercially Available Heart Rate Monitors II
In 2015, over 85 million fitness wearables were sold worldwide and the market is projected to expand to 110 million units sold in 2017.
- Trial name
- NCT02818244
- Testing
- Fit Bit Blaze Heart Rate Monitoring Device, Garmin Forerunner 235 Heart Rate Monitoring Device, Tom Tom Spark Cardio Heart Rate Monitoring Device
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- The Cleveland Clinic
Anemia, Diabetes
A Comparative Clinical Trial of the TensorTip, a Novel Non Invasive Device for Measurement Blood Parameters
1. Aim: The aim of the clinical trial is to study the accuracy of the TensorTip device compared with registered (FDA-approved) invasive and non-invasive devices. 2.
- Conditions
- Anemia, Diabetes, Heart Disease, High Blood Pressure
- Trial name
- NCT01196533
- Testing
- Non invasive peripheral blood monitoring
- Where
- United States
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Cnoga Medical Ltd.
Healthy
Accuracy of SpO2 for Noninvasive Pulse Oximeter Sensor (LNCS ADTX)
In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the study volunteer breathes.
- Trial name
- NCT03125018
- Testing
- LNCS ADTX Sensor
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Device Latency
Substudy of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)
The purpose of this study was to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.
- Trial name
- OSMITTER (NCT02091882)
- Testing
- Combination product of Aripiprazole + IEM + Sensor + MIND1 Application
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Surgery, Hip Osteoarthritis
Two Year Study With Robotic-Arm Assisted Hip Surgery.
This study will involve a quantitative assessment of prospectively collected computed tomography, radiographic and patient outcomes data from multiple centers.
- Trial name
- NCT03891199
- Testing
- Robotic-Arm Assisted THA
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- West Virginia University
Febrile Illness
Timmy3 Module Clinical Accuracy ISO 80601-2-56:2017 + A1 2018
The purpose of this document is to validate the clinical accuracy of the TIMMY3 thermometry module, integrated into host device CVSM, according to ISO 80601-2-56:2017 + A1 2018.
- Trial name
- NCT06056011
- Testing
- Connex CVSM with Timmy3 module
- Where
- 5 sites in United States
- Volunteers
- 373 people, healthy volunteers welcome
- Sponsor
- Baxter Healthcare Corporation
Arterial Disease
Vital USA SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry
Clinical Investigation Plan: Vital USA SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry Study ID# PR 2019-353, Version: Rev 1, Date: 15 Oct 2019 Study Dates: November 4-5, 2019
- Trial name
- NCT04285411
- Testing
- Accuracy of the VitalDetect™ pulse oximetry system
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Vital USA, Inc.
Amblyopia, Strabismus
Improving Quality Vision Outcomes in Managed Care Setting While Reducing Cost by Use of Accurate, Automated Screening
Amblyopia ("lazy eye") and strabismus (misaligned eyes) are medical eye conditions that combine as the leading causes of preventable vision loss in children.
- Trial name
- NCT02536963
- Testing
- Pediatric Vision Scanning device, Reference examination
- Where
- United States
- Volunteers
- 318 people, healthy volunteers welcome
- Sponsor
- Rebiscan, Inc.
Gather Feasibility Data and User Feedback on Use of a Device in Vivo on Pregnant Volunteers in Their 2nd and 3rd Trimester
Vscan Access R2 Feasibility Evaluation
This study is being done to evaluate if the Vscan Access R2 Ultrasound System can measure Fetal Heart Rate (FHR) in humans when compared against a reference device (GE Corometrics 170 Series Fetal Monitor), and to gather feedback…
- Trial name
- NCT03617419
- Testing
- GE VScan Access R2 Ultrasound System, GE Corometrics 170 Series Fetal Monitor
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GE Healthcare
Breast Cancer
Case Collection Study to Support Digital Mammography Image Software Change
The primary objective of this study is to compare image processing software to support a new image processing software application for a full-field digital mammography (FFDM) system.
- Trial name
- LIP2SIP (NCT00756496)
- Testing
- Mammography screening and diagnosis
- Volunteers
- 442 people, healthy volunteers welcome
- Sponsor
- Siemens Medical Solutions USA - CSG
Measure Accuracy of Respiratory Rate
Respiratory Rate Validation Study
The purpose of this study is to conduct a Respiratory Rate accuracy validation on pediatrics population comparing the Gabi SmartCare Gabi Band to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex- Ohmeda)…
- Trial name
- NCT05856422
- Testing
- Respiratory rate measure based on PPG
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Gabi SmartCare
Stone, Kidney, Ultrasound Therapy; Complications
Accuracy of Ultrasound for Detecting Residual Fragments During RIRS
The purpose of this study is to assess the accuracy of ultrasound and traditional fluoroscopy to find the residual fragments before retrograde intrarenal surgery is complete.
- Trial name
- NCT05535816
- Testing
- Ultrasound
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Healthy, Hypoxia
SpO2 Accuracy of Noninvasive Disposable Pulse Oximeter Sensor
The purpose of this clinical study is to validate the SpO2 accuracy of the Stryker Sustainability Solutions pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples…
- Trial name
- NCT05245526
- Testing
- STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Stryker Sustainability Solutions
Healthy
Accuracy of Methemoglobin Measurement of Various Rainbow Pulse Oximeter Sensors
In this study, the level of methemoglobin (HbMet) will be increased in a controlled manner by administering sodium nitrite intravenously in healthy volunteers.
- Trial name
- NCT03124836
- Testing
- Pulse Oximeter Sensor
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Healthy
Accuracy of Commercially Available Heart Rate Monitors
Over the last two decades, there has been a proliferation of commercially available heart rate monitors. Recognizing that elite athletes often use heart rate to monitor training and assess aerobic fitness, fitness companies have…
- Trial name
- HRM (NCT02697214)
- Testing
- Fitbit Charge HR, Apple Watch, Mio Fuse
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- The Cleveland Clinic
Elbow Injury, Elbow Fracture
Pocket Sized Ultrasound (PsUS) and Pediatric Elbow Fractures
The main purpose of this project is to investigate the accuracy of pocket-sized ultrasound (PsUS) in the diagnosis of pediatric elbow fractures.
- Trial name
- NCT05870345
- Testing
- Butterfly IQ
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- University of Chicago
Breast Cancer
Accurate, Rapid and Inexpensive MRI Protocol for Breast Cancer Screening
The purpose of this study is to test an innovative MRI breast cancer screening method in women with mammographically dense breasts as well as other women with moderately increased cancer risk.
- Trial name
- NCT04877912
- Testing
- MRI Abbreviated Scan, Abbreviated MRI Scan
- Where
- United States
- Volunteers
- 166 people, healthy volunteers welcome
- Sponsor
- University of Chicago