Clinical trials: Accuracy
Tuberculosis (TB)
QuantiFERON Access Clinical Performance Study Protocol
Approximately 225 samples, obtained from participants with varying risk factors for TB infection and disease, will be tested using the QFT Access Kit and the comparator device QFT-Plus.
- Trial name
- NCT04243031
- Testing
- QFT Access
- Volunteers
- healthy volunteers welcome
- Sponsor
- QIAGEN Gaithersburg, Inc
Temperature Change, Body
Validation of the Measurement Accuracy of the Tcore Thermometer
The aim of the study conducted at the UKSH is to investigate the measuring accuracy of the body core temperature thermometer Tcore®.
- Trial name
- T-CORE-PMCF (NCT04489927)
- Testing
- Tcore
- Where
- Germany
- Volunteers
- 75 people
- Sponsor
- Drägerwerk AG & Co. KGaA
Asthma, COPD
Assess Accuracy of Primary Care Asthma and COPD Diagnosis Using Oscillometry and FeNO vs Specialist Diagnosis
Current diagnostic methods for asthma and chronic obstructive pulmonary disease mostly depend on pulmonary function tests, especially spirometry.
- Trial name
- Care4All (NCT07245576)
- Where
- 12 sites in Argentina, Egypt and 5 more
- Volunteers
- 600 people
- Sponsor
- AstraZeneca
Dry Eye
A Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/Keratometry and Postoperative Refractive Accuracy
A Phase 4, Multicenter, Open-Label Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/ Keratometry and Postoperative Refractive Accuracy
- Trial name
- NCT06346340
- Testing
- Miebo
- Where
- 12 sites in United States
- Volunteers
- 97 people
- Sponsor
- Bausch & Lomb Incorporated
Acute Myocardial Infarction (AMI)
SpinChip Hs-cTnI Multisite Precision
During a heart attack, the protein troponin I is released from the heart muscle into the bloodstream. Measurements of cardiac troponin in blood are used as an aid in the diagnosis of heart attack.
- Trial name
- HEAT-1 (NCT06851013)
- Testing
- SpinChip hs-cTnI
- Where
- 3 sites in Norway
- Volunteers
- 37 people
- Sponsor
- SpinChip Diagnostics ASA
Amyotrophic Lateral Sclerosis (ALS)
A Study to Evaluate the Performance of a Diagnostic Test in ALS
Prospective multicenter study of subjects who were recently diagnosed with amyotrophic lateral sclerosis (ALS) or another neurodegenerative disease (including spinal cord diseases, muscle diseases and neurological diseases such…
- Trial name
- NCT02759913
- Testing
- Lumbar puncture
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Iron Horse Diagnostics, Inc.
Type 1 Diabetes, Type 2 Diabetes
Adult Accuracy Study of the Enlite 3 Glucose Sensor
The purpose of this study is to demonstrate the performance of the Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen and used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years with type 1…
- Trial name
- E3 (NCT02246582)
- Testing
- Enlite 3, Guardian Mobile App, 640G Insulin Pump
- Where
- 6 sites in United States
- Volunteers
- 118 people
- Sponsor
- Medtronic MiniMed, Inc.
Lung Cancer
superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology
The purpose of this investigation is to confirm the clinical accuracy of the superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology.
- Trial name
- NCT03585959
- Testing
- superDimension™ Navigation System Version 7.2
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Medtronic - MITG
Multiple Sclerosis
Assessment of Subject Use of the Rebiject II Injection Device According to Nurse Examination of Subject Accuracy in 10 Steps as a Dummy Demonstration
Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating disease of the central nervous system (CNS) and is one of the most common causes of neurological disability in young adults.
- Trial name
- NCT01195857
- Volunteers
- 100 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Deep Vein Thrombosis
Clinical Trial to Evaluate the Accuracy of [99mTc] ThromboView in the Detection of Deep Vein Thrombosis
The assessment of patients with suspected deep vein thrombosis (DVT) is a common clinical scenario that, despite major advances in diagnostic testing, continues to be challenging.
- Trial name
- NCT00123734
- Testing
- ThromboView
- Where
- 12 sites in United States, Canada
- Volunteers
- 94 people
- Sponsor
- Agen Biomedical
Oximetry
EmbracePlus SpO2 Accuracy Validation
The aim of this study is to test the accuracy of EmbracePlus computed SpO2 during mild, moderate and severe hypoxia (a lower-than-normal concentration of oxygen in arterial blood); ie, a range of arterial HbO2 saturations from…
- Trial name
- NCT04964609
- Testing
- EmbracePlus
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Empatica, Inc.
Normal Pressure Hydrocephalus
ShuntCheck Accuracy in Detecting Shunt Obstruction Normal Pressure Hydrocephalus (NPH) Patients
The purpose of this study is to examine the role of ShuntCheck and MR Imaging in evaluating the presence or absence of Shunt Obstruction in the patients of Hydrocephalus or Idiopathic Intracranial Hypertension (IIH) undergoing…
- Trial name
- NCT00793416
- Testing
- Shunt flow detection
- Where
- United States
- Sponsor
- NeuroDx Development
Diabetes Mellitus
Evaluation of the Accuracy of an Implanted Glucose Sensor
The purpose of this clinical investigation is to evaluate the accuracy of the Senseonics Continuous Glucose Monitoring System (Senseonics CGM System) measurements when compared with reference standard measurements The…
- Trial name
- PRECISEII (NCT02647905)
- Testing
- Continuous Glucose Monitoring System
- Where
- 9 sites in United States
- Volunteers
- 90 people
- Sponsor
- Senseonics, Inc.
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
Healthy, Febrile Illness
Prospective Study to Validate the Clinical Accuracy of Norbert Device to Measure Body Temperature
The study will evaluate the clinical bias and clinical repeatability of measuring body temperature using the Norbert Device (ND).
- Trial name
- NCT05640310
- Testing
- Norbert Device
- Volunteers
- healthy volunteers welcome
- Sponsor
- Norbert Health
Bone Metastases, Fractures, Bone
EPIBONE Study: a Prospective Study on Feasibility, Safety and Accuracy
Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for bone percutaneous procedures.
- Conditions
- Bone Metastases, Fractures, Bone, Bone Tumor
- Trial name
- EPIBONE (NCT06376682)
- Testing
- CT-guided bone percutaneous procedure
- Where
- 3 sites in France
- Volunteers
- 34 people
- Sponsor
- Quantum Surgical
Melanoma
MElanoma Research Lymph Node Prediction Implementation National_001
MERLIN_001 is a prospective registry study of a primary melanoma gene-signature to predict sentinel node (SN) status and to determine its prognostic value for more accurate staging of SN-negative melanoma patients.
- Trial name
- MERLIN_001 (NCT04759781)
- Where
- 9 sites in United States
- Volunteers
- 1,820 people
- Sponsor
- SkylineDx
Influenza -Like Illness, Influenza A
Home Testing of Respiratory Illness
The main goal of this research study is to use data from activity trackers (such as Fitbits), lab tests, and surveys to see if activity, sleep, and heart rate data can tell the difference between when someone has a respiratory…
- Conditions
- Influenza -Like Illness, Influenza A, Influenza Type B, Respiratory Viral Infection
- Trial name
- NCT04245800
- Where
- United States
- Volunteers
- 5,233 people, healthy volunteers welcome
- Sponsor
- Evidation Health
Coronary Artery Disease
Evaluation of Diagnostic Accuracy of MCG(Magnetocardiography) Scan in Suspected Coronary Artery Disease
This multicenter clinical trial is designed to evaluate the diagnostic accuracy of MCG scan in detecting significant CAD compared to the reference standard CAG.
- Trial name
- EDAM-CAD (NCT05825911)
- Testing
- Rest/Stress MCG scan, Rest MCG scan
- Where
- 2 sites in South Korea
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- AMCG
Surgery, Healthy
Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor
In this study, the concentration of hemoglobin within the subject's blood is affected by fluid status changes. The fluid status is affected by fluid loss during surgery for hospitalized study subjects or controlled administration…
- Trial name
- NCT03124901
- Testing
- DCI pulse oximeter sensor
- Where
- 2 sites in United States
- Volunteers
- 147 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation