Clinical trials: Diagnostic Accuracy
Breast Cancer Diagnosis
Evaluation of Diagnostic Accuracy of Contrast Enhanced Dual Energy Mammography Imaging in Comparison to CE-MRI
Clinical study to evaluate diagnostic accuracy of low dose contrast enhanced dual energy mammography imaging (CEDEM+PRIME) in comparison with CE-MRI The primary objective of this clinical study is to assess diagnostic accuracy in…
- Trial name
- CEDEM (NCT02608281)
- Testing
- CONTRAST ENHANCED DUAL ENERGY (CEDEM)
- Where
- Austria
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Siemens Healthcare QT
Chlamydia, Gonorrhea
Screening With Tampons: Evaluating Diagnostic Accuracy and HPV and Assessing Participant Views
Diagnostic trial comparing the diagnostic accuracy of the DAYE Diagnostic Tampon (DDT) with a vaginal swab (self-collected and clinician taken).
- Conditions
- Chlamydia, Gonorrhea, Bacterial Vaginosis, Human Papilloma Virus
- Trial name
- STAMP (NCT06154239)
- Testing
- DAYE Diagnostic Tampon, Vaginal self-swab, Clinician vaginal swab
- Where
- United Kingdom
- Volunteers
- 617 people, healthy volunteers welcome
- Sponsor
- Anne's Day Ltd
Diagnostic Techniques and Procedures, Clinical Laboratory Techniques
Clinical Validation of an Artificial Intelligence System for the Interpretation of Laboratory Test Results Combined With a Structured Medical History
This study evaluates a certified artificial intelligence (AI) based software system that automatically interprets laboratory test results in combination with a structured, dynamically generated medical history questionnaire.
- Conditions
- Diagnostic Techniques and Procedures, Clinical Laboratory Techniques, Triage
- Trial name
- LTC-VALID (NCT07810491)
- Testing
- AI-based laboratory result interpretation software
- Where
- 2 sites in Poland
- Volunteers
- 899 people
- Sponsor
- Labplus Sp. z o.o.
Lower Respiratory Tract Infection, Acute Bronchitis
Evaluating a Host-response Based Diagnostic for Distinguishing Between Bacterial and Viral Etiology in Patients With Lower Respiratory Tract Infection (LRTI)
The purpose of this study is to validate the diagnostic accuracy of a novel host-response based diagnostic tool for differentiating between bacterial and viral etiologies in adult patients aged 18 years and older with clinical…
- Conditions
- Lower Respiratory Tract Infection, Acute Bronchitis, Pneumonia, Chronic Obstructive Pulmonary Disease (COPD)
- Trial name
- OBSERVER (NCT03011515)
- Where
- Israel
- Volunteers
- 583 people, healthy volunteers welcome
- Sponsor
- MeMed Diagnostics Ltd.
Obstructive Sleep Apnea
Exploration of Current and New Technologies for Accuracy of Diagnosing OSA
Resmed is the manufacturer of medical devices which screen, diagnose, treat and monitor people with sleeping and respiratory disorders, such as obstructive sleep apnea (OSA).
- Trial name
- NCT07485582
- Testing
- Device A, Device B, Device C
- Where
- 5 sites in Australia
- Volunteers
- 90 people
- Sponsor
- ResMed
Lung Cancer
Diagnostic Accuracy Study for OWL-EVO1 as a Lung Cancer EVOC® Probe (Evolution Phase 2)
The Phase 2a Evolution study aims to assess the diagnostic accuracy of the OWL-EV1 Probe Breath Biopsy Test to differentiate between individuals with lung cancer and relevant contrast groups.
- Trial name
- NCT06193239
- Testing
- OWL-EVO1
- Where
- 9 sites in Czechia, Hungary and 1 more
- Volunteers
- 187 people
- Sponsor
- Owlstone Ltd
Mild Cognitive Impairment and Dementia
UK Validation of the Automated "AcceXible" Speech Analysis Software
Dementia, especially dementia caused by Alzheimer's disease, is considered one of the most severe health problems of our time. It is currently known that the disease begins many years before clinical symptoms appear.
- Trial name
- NCT05534958
- Testing
- Accexible
- Where
- United Kingdom
- Volunteers
- 221 people
- Sponsor
- Accexible
Breast Cancer, Tumors, Breast
Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography (ADAPT)
The aim of this recruitment plan (ADAPT-BX) is to collect image and technical data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with other subject data including histology results…
- Trial name
- ADAPT (NCT02324205)
- Testing
- DBT and FFDM
- Where
- 3 sites in United States, France
- Volunteers
- 196 people
- Sponsor
- GE Healthcare
Retinopathy of Prematurity, ROP
Validation of i-ROP DL to Detect More Than Mild ROP
The purpose of the pivotal reader study is to assess the readers' accuracy in diagnosing plus disease versus no plus or pre-plus disease with or without the aid of the i-ROP DL.
- Trial name
- NCT06109285
- Testing
- iROP DL
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Siloam Vision
Breast Cancer Diagnosis
PMA Required Pivotal Multi-reader Multi-case Reader Study
A pivotal multi-reader multi-case (MRMC) study to compare the diagnostic performance of 3D Koning Breast Computed Tomography (KBCT) to that of 2D Diagnostic Mammography to support the Pre-market Approval (PMA) of KBCT by the US…
- Trial name
- NCT01952717
- Volunteers
- 236 people
- Sponsor
- Koning Corporation
Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
Expansion of SCG/GCG-Based CAD Sceering: Inclusion of Healthy Controls and CCTA Patients
This study evaluates a new, non-invasive method for screening coronary artery disease (CAD) using seismocardiography (SCG) and gyrocardiography (GCG).
- Trial name
- HF-CAD-CCTA (NCT06880133)
- Testing
- Seismocardiography (SCG) and Gyrocardiography (GCG) Screening
- Where
- Uzbekistan
- Volunteers
- 1,600 people, healthy volunteers welcome
- Sponsor
- Heart Force Medical Inc.
Sepsis
Adult MDW Dual Cut-Off Accuracy Study
This study will establish the clinical performance of the Monocyte Distribution Width (MDW) parameter on the DxH 900/ DxH 690T hematology analyzers to aid in the detection and risk assessment of patients in the Emergency…
- Trial name
- MDW (NCT06885528)
- Testing
- Complete Blood Count with differential
- Where
- 5 sites in United States
- Volunteers
- 524 people
- Sponsor
- Beckman Coulter, Inc.
Phenylketonuria (PKU)
A Self-test Home-use Blood Phenylalanine Monitoring System Under the Brand Name Egoo Phe System Has Been Developed for Measurement of Phenylalanine (Phe) in Individuals Diagnosed With Phenylketonuria (PKU): The Study Purpose is to Evaluate Accuracy and Usability
A home-use self-test blood phenylalanine monitoring system under the brand name Egoo Phe System from manufacturer Egoo Health Aps has been developed for measurement of phenylalanine (Phe) in individuals diagnosed with…
- Trial name
- NCT06940193
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Egoo Health Aps
Non-alcoholic Fatty Liver Disease
Prospective, Cross-sectional and Multicenter Study, Evaluating the Diagnosis Accuracy of the Controlled Attenuation Parameter(CAP) Measured by FibroScan® (Either With M+ or XL+ Probe) in Patient With Non-Alcoholic Fatty Liver Disease Using Liver Biopsy as Reference.
The non-alcoholic fatty liver disease (NAFLD) represents the most common cause of liver disease in the western world. It can progress from steatosis to non-alcoholic steatohepatitis (NASH), and then onto cirrhosis where there is…
- Trial name
- NCT01985009
- Testing
- FibroScan® examination.
- Where
- 7 sites in United Kingdom
- Volunteers
- 450 people
- Sponsor
- Echosens
Epilepsy
Epilepsy Seizure Detection With Innovative Tripolar EEG (tEEG)
Concurrent electroencephalography (EEG) and new tripolar EEG (tEEG) will be recorded from adult and pediatric patients. In some patients stereo EEG (sEEG) will also be recorded concurrently.
- Trial name
- NCT05944692
- Testing
- Tripolar electroencephalography
- Where
- 2 sites in United States
- Volunteers
- 90 people
- Sponsor
- CREmedical
Coronary Artery Disease, Cardiovascular Diseases
Functional Diagnostic Accuracy of Quantitative Flow Ratio in Tandem Lesions and Virtual Stenting
Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. Virtual stent implantation technique combined with QFR was recently developed to predict the functional significance…
- Conditions
- Coronary Artery Disease, Cardiovascular Diseases, Myocardial Ischemia, Arterial Occlusive Diseases
- Trial name
- FORTRESS (NCT03405506)
- Testing
- Quantitative Flow Ratio (QFR)
- Where
- China
- Volunteers
- 308 people
- Sponsor
- Pulse Medical Imaging Technology (Shanghai) Co., Ltd
Glioma, 18F-Fluoroethyl-l-tyrosine
Clinical Benefit of 18F-FET in Glioma.
This Phase II clinical trial, sponsored by Primo Biotechnology Co., Ltd., evaluates the clinical benefit of $^{18}$F-FET PET/CT in diagnosing glioma.
- Trial name
- NCT07698457
- Testing
- 18F-Fluoroethyl-l-tyrosine
- Where
- 4 sites in Taiwan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Primo Biotechnology Co., Ltd