Clinical trials: Accuracy
Hypoxia
Accuracy of Pulse Oximeters in Profound Hypoxia
The goal of this study was to evaluate the accuracy of pulse oximeters over the range of 70-100%. Two devices were placed on each subject with one on the finger and the other on the fingertip.
- Trial name
- NCT05920278
- Testing
- Pulse oximeter
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Movano Health
Bioelectrical Impedance Measurement of Healthy Adults
Comparing Medical Body Composition Analyzer Seca mBCA 555 With Seca mBCA 515
The mBCA 515 was compared to the gold standard methods MRI, DXA, ADP, D2O- and NaBr-dilution in previous clinical investigations (BCA-01, BCA-02, BCA-20) to generate prediction equations for calculating body composition (FFM…
- Trial name
- NCT04030416
- Where
- Germany
- Volunteers
- 120 people
- Sponsor
- Seca GmbH & Co. Kg.
Healthy, Arrhythmia
Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Pulse Rate
The study will evaluate the mean average error (MAE) of measuring pulse rate using the Norbert Device (ND) as compared to a reference heart rate measured using an electrocardiogram (ECG).
- Trial name
- NCT05640323
- Testing
- Norbert Device
- Where
- 2 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Norbert Health
Lung Cancer Screening
Clinical Evaluation of the Lung Cancer AI-based Decision Support Tool in Low-Dose Lung CT
The goal of this observational study is to clinically validate the accuracy of an AI-based decision support tool-the Lung Cancer Detection System (LCDS)-for detecting lung nodules in asymptomatic adults aged 50-79 with a history…
- Trial name
- GenMedAILCSD1 (NCT07052773)
- Testing
- Lung Cancer Detection System (LCDS)
- Where
- Israel
- Volunteers
- 100 people
- Sponsor
- Genesis Medical AI
Primary Total Hip Arthroplasty
Accuracy of OPS™ Femoral Neck Resection Study
The primary objective of this study is to determine the accuracy of the Optimized Positioning System (OPS™) planning and delivery tools using different types of surgical approaches.
- Trial name
- NCT03956381
- Testing
- Primary Total Hip Replacement with Trinity cup and TriFit TS stem via posterolateral surgical approach., Primary Total Hip Replacement with Trinity cup and MetaFix stem via direct anterior surgical approach
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Corin
Thyroid
A Prospective, Single-arm, Multi-centre, Blinded, Observational, Diagnostic Accuracy Study With a Diagnostic Medical Product
After thyroid surgery, 0.6 to 4% of patients develop postoperative bleeding. 90% of this postoperative bleeding occurs within the first 48 hours.
- Trial name
- HEDOS (NCT04845867)
- Testing
- ISAR-M THYRO
- Where
- Germany
- Volunteers
- 1,470 people
- Sponsor
- ISAR-M GmbH
Respiratory Disorder, Cardiovascular Diseases
Study of RE.DOCTOR Vitals® Software Accuracy
The purpose of this observational trial is to advance digital health monitoring through the analysis of Photoplethysmography (PPG) waveforms collected via RE.DOCTOR Vitals software.
- Conditions
- Respiratory Disorder, Cardiovascular Diseases, Diabetes, Pre-Diabetes
- Trial name
- RE-VITAL (NCT06237322)
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- RE.DOCTOR LLC
Heart Failure
Accuracy of Cardiac Acoustic Biomarkers Recorded by the Wearable Cardioverter Defibrillator
Evaluate data accuracy of cardiac acoustic biomarkers (CABs) recorded by the Wearable Cardioverter Defibrillator (WCD) as compared to the AUDICOR AM acoustic cardiography recorder.
- Trial name
- ACAB (NCT04292405)
- Testing
- Wearable Cardioverter Defibrillator
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Zoll Medical Corporation
Healthy, Hypoxia
Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Oxygen Saturation
The purpose of this study is to evaluate the SpO2 accuracy and performance of the Norbert Device during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-oximetry for SpO2…
- Trial name
- NCT05685654
- Testing
- Norbert Device
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Norbert Health
Air Leak From Lung, Pneumothorax
Feasibility and Accuracy of a Novel Pleural Drain Gas Analyzer in Detecting Air Leaks
The goal of this study is to assess the clinical feasibility of a novel, reusable, low cost gas analyzer that detects breath in chest drains in order to diagnose and heal air leaks.
- Trial name
- NCT06548386
- Testing
- Pleural gas analysis
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Lung Healing Technologies Inc
Premature Ventricular Contraction, Ventricular Tachycardia
VIVO™ Accuracy Study
A multi-center study designed to assess the accuracy of VIVO™ in determining the location of a PVC/VT foci in comparison to an electroanatomical mapping system.
- Trial name
- NCT03340142
- Testing
- VIVO™
- Where
- 3 sites in United States
- Volunteers
- 45 people
- Sponsor
- Catheter Precision. Inc.
Sleep Apnea Syndrome
Comparing the Sleep Strip OTC™ Accuracy in Screening for Sleep Apnea Syndrome Against the Reference Method, an In-lab Full Night Polysomnographic (PSG)
The primary purpose of this study is to demonstrate the equivalence of the new Sleep Strip OTC(TM) compared to the reference method of an in-lab, attended full-night polysomnographic (PSG) study.
- Trial name
- NCT00942669
- Testing
- SleepStrip OTC(TM)
- Where
- Israel
- Volunteers
- 80 people
- Sponsor
- Scientific Laboratory Products, Ltd.
Diabetes
System Accuracy and User Performance of Blood Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus
The aim of this test is to determine the system accuracy and user performance evaluation of three Blood Glucose Monitoring systems.
- Trial name
- NCT02290067
- Testing
- Blood glucose monitoring system (Omnitest 3), Blood glucose monitoring system (Omnitest 5), Blood glucose monitoring system (Omnitest 5D)
- Where
- Germany
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- B. Braun Melsungen AG
Diabetes Mellitus
FreeStyle Libre Continuous Glucose Monitoring System Accuracy Study
The purpose of this study is to characterize the Freestyle Libre Glucose Monitoring System in pediatric and adult subjects with respect to YSI reference venous plasma sample measurements.
- Trial name
- NCT04464772
- Testing
- FreeStyle Libre 3
- Where
- 4 sites in United States
- Volunteers
- 85 people
- Sponsor
- Abbott Diabetes Care
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.
type1diabetes, CGM
Evaluation of the Accuracy and Safety of a Continuous Glucose Monitoring System
The study is to evaluate the accuracy and safety of a real-time CGM system among adult patients with type 1 diabetes with respect to reference venous plasma sample measurements.
- Conditions
- type1diabetes, CGM, T1D
- Trial name
- NCT07745244
- Testing
- GS3 CGM
- Where
- China
- Volunteers
- 36 people
- Sponsor
- SiBionics, Co, Ltd
Diabetes Mellitus
FreeStyle Libre Flash Accuracy Study
This is a non-randomized, single arm, multi-center, prospective, non-significant risk study to evaluate the FreeStyle Libre Flash Glucose Monitoring System.
- Trial name
- NCT03257501
- Testing
- FreeStyle Libre Flash Glucose Monitoring System
- Where
- 4 sites in United States
- Volunteers
- 104 people
- Sponsor
- Abbott Diabetes Care
Upper Respiratory Infections
Evaluation of Accuracy and Ease of Use of the FilmArray™ Respiratory Panel (RP EZ) in a CLIA-Waived Clinical Setting
The purpose of this study is to assess the accuracy and ease-of-use of a simplified FilmArray Respiratory Panel test (FilmArray RP EZ) when performed according to the manufacturer's instructions by personnel in laboratories…
- Trial name
- NCT02232711
- Where
- 4 sites in United States
- Volunteers
- 1,082 people
- Sponsor
- BioFire Diagnostics, LLC
Diabetes Mellitus
Accuracy and Precision of the True Vie I3 Continuous Glucose Monitoring System: an Open Label, Multi-Center Trial
The purpose of the investigation is to evaluate the performance of the I3 CGM according to the FDA's special controls for iCGM.
- Trial name
- NCT05806554
- Testing
- Continuous glucose monitoring device
- Where
- 6 sites in United States, Germany
- Volunteers
- 159 people
- Sponsor
- Sinocare
Attention-Deficit, Hyperactivity Disorder
Diagnostic Accuracy and Safety of the Attention-Deficit/Hyperactivity Disorder Auxiliary Evaluation System (AHEF) in Chinese Children Aged 6 to 12
This clinical trial aims to evaluate the diagnostic efficacy and safety of the Attention Deficit Hyperactivity Disorder Assessment System (AHEF) in children aged 6 to 12 in China, while ensuring the safety of the subjects and…
- Trial name
- NCT07683156
- Testing
- AHEF
- Where
- 8 sites in China
- Volunteers
- 570 people, healthy volunteers welcome
- Sponsor
- Chongqing Jinsaixing Medical Technology Co., Ltd