Clinical trials: Diagnostic Accuracy
- Condition Diagnostic Accuracy
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
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
Autism, Autism Spectrum Disorder
Online Evaluation of the Diagnostic Accuracy of BlinkLab's Digital Assessments for Autism
This observational study aims to evaluate how patterns of behavioral and sensorimotor responses measured using the BlinkLab Dx1 smartphone application relate to autism diagnoses in children ages 2 to 11.
- Conditions
- Autism, Autism Spectrum Disorder, Autism Spectrum Disorder (ASD), Neurodevelopmental Conditions
- Trial name
- NCT07590973
- Testing
- BlinkLab Dx1, Retrospective Neurodevelopmental Diagnostic Assessment
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Blinklab Limited
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
Antenatal Care, Maternal Health
AI Blind-Sweep Ultrasound for Antenatal Screening by Non-Specialist Health Workers in Rural DR Congo
FS2 evaluates the diagnostic accuracy and implementation feasibility of an AI-assisted blind-sweep obstetric ultrasound (SPAQ E-con AI), operated by trained non-specialist health workers, for antenatal screening in rural…
- Conditions
- Antenatal Care, Maternal Health, Gestational Age, Placenta Praevia
- Trial name
- FS2 (NCT07677670)
- Testing
- SPAQ E-con AI blind-sweep ultrasound
- Where
- Democratic Republic of the Congo
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- SOIK Corporation Sarl
Cancer, Metabolic Disease
An Observational Study On TheAccuracy Of Whole-Body Magnetic Resonance Imaging (Wb-Mri) ScreeningTo Predict Clinically Significant Diagnoses In General Population Subjects Interested In Proactive And Advanced General Preventive Healthcare.
This is a prospective, single-arm, observational study capturing data from whole-body magnetic resonance imagining (WB-MRI) from up to 100,000 male and female subjects 18 years of age or older recruited at multiple clinical sites…
- Conditions
- Cancer, Metabolic Disease, Aneurysm, Neurologic Disorder
- Trial name
- Hercules (NCT06212479)
- Testing
- MRI Scan
- Where
- United States
- Volunteers
- 100,000 people, healthy volunteers welcome
- Sponsor
- Hercules
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.
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
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.
Endometriosis, Diagnosis
Proof of Concept Study to Eval MetriDx Lab-developed Test to Identify Endometriosis-specific Bio Markers
This study is testing a way to diagnose endometriosis using a uterine tissue biopsy (similar to a pap smear) as opposed to undergoing laparoscopy surgery.
- Trial name
- NCT05698212
- Testing
- MetriDx
- Where
- 3 sites in United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Hera Biotech, Inc.
Differential Diagnosis, Diagnostic Accuracy
Evaluation of One-Shot Vision Differential Diagnosis (OSVDE) and Multi-Step Conversational Non-Inferiority (MSCNE) in AI Medical Interviewing
This study evaluates the diagnostic performance of a multimodal artificial intelligence (AI) system (AIMD.1) using de-identified medical images and semi-synthetic patient simulations.
- Trial name
- OSVDE-MSCNE (NCT07470463)
- Testing
- AI Diagnostic System (AIMD.1)
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Magic Health Inc. (d.b.a. Nolla Health)
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.
High Risk Cancer, Lung Cancer
Retrospective Clinical Trial Comparing Radiologists' Diagnosis Accuracy in Lung Cancer Screening Population With and Without the Help of an AI/ML Tech-based SaMD
This is a two arm, randomized, controlled, blinded, multi-case multi reader (MRMC), retrospective study for the evaluation of the efficacy and safety of an AI/ML technology-based CADe/x developed to detect, localize and…
- Trial name
- RELIVE (NCT06751576)
- Testing
- Median LCS
- Where
- 5 sites in United States, Spain
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- Median Technologies
Otitis Media Acute
Clinical Development of Deep Learning for the OtoSight
The objective of this study is to clinically develop and evaluate a machine learning approach to improve the performance and data interpretation of the PhotoniCare OtoSight Middle Ear Scope in pediatric patients presenting at the…
- Trial name
- NCT04722770
- Testing
- PhotoniCare OtoSight Middle Ear Scope
- Where
- United States
- Volunteers
- 188 people, healthy volunteers welcome
- Sponsor
- PhotoniCare, Inc.
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
Allergy, Hypersensitivity, Immediate
Head-to-Head Comparison Study Between Different FDA Registered Allergy Skin Test Applicators
This clinical study, titled "Head-to-Head Comparison Study between Different FDA Registered Allergy Skin Test Applicators," aims to compare the reliability and clinical performance of three skin prick test (SPT) devices…
- Conditions
- Allergy, Hypersensitivity, Immediate, Ig-E Mediated Food
- Trial name
- NCT07400718
- Testing
- AllerTest-10 Multi-Head Skin Test Device, Skintestor OMNI Multi-Head Skin Test Device, Multi-Test II Multi-Head Skin Test Device
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- QHSLab, Inc.
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
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
Breast Cancer
Study to Compare the Diagnostic Accuracy of Nuance Full-Field Digital Mammography to Screen-Film Mammography
Evaluate the diagnostic accuracy of the Planmed Sophie Nuance Full Field Digital Mammography (FFDM) X-ray System compared to screen-film mammography (SFM) in the detection of breast cancer.
- Trial name
- NCT00942396
- Testing
- Full Field Digital Mammogram (Planmed Sophie Nuance)
- Where
- 2 sites in United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Planmed Oy
Cow's Milk Allergy
Diagnostic Accuracy and Safety of DBV1605 for the Diagnosis of Non-IgE Mediated Cow's Milk Allergy in Children
Study to assess the diagnostic accuracy (sensitivity, specificity, positive and negative predictive value) of DBV1605 for the diagnosis of non-Immunoglobulin E (IgE) mediated cow's milk allergy (CMA) in children with symptoms…
- Trial name
- APTITUDE (NCT04492683)
- Testing
- DBV1605
- Where
- 33 sites in United States, Canada and 2 more
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- DBV Technologies
Breast Neoplasms, Breast Cancer Detection
Diagnostic Accuracy of Carebot AI MMG in Mammography Screening: Multicenter MRMC Study
This study evaluates the diagnostic performance of Carebot AI MMG, an artificial intelligence (AI)-enabled medical device for evaluating mammograms.
- Conditions
- Breast Neoplasms, Breast Cancer Detection, Breast Cancer - Female, Breast Cancer Screening
- Trial name
- CARE-MMG-MRMC (NCT07298252)
- Testing
- Carebot AI MMG software analysis
- Where
- 4 sites in Czechia, Slovakia
- Volunteers
- 222 people, healthy volunteers welcome
- Sponsor
- Carebot s.r.o.