Clinical trials: Reader Study
Vision-Threatening Retinal Lesions, Urgent Referral Retinal Findings
Artificial Intelligence-Assisted Lesion-Based Urgent Referral Triage of Ultra-Widefield Retinal Images
his study evaluates the clinical utility of an artificial intelligence (AI)-assisted lesion-based urgent referral triage system for ultra-widefield (UWF) retinal images.
- Conditions
- Vision-Threatening Retinal Lesions, Urgent Referral Retinal Findings, Retinal Detachment, Pre-retinal Hemorrhage
- Trial name
- ALERT-UWF (NCT07643129)
- Testing
- AI-Assisted UWF Lesion-Based Triage System, Unassisted Interpretation
- Where
- China
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Xiamen Ophthalmology Center Affiliated to Xiamen University
Lung Cancer
AI-Assisted Chest CT Interpretation Across the Lung Cancer Care Continuum
This investigator-initiated, single-center study consists of a retrospective artificial intelligence model-development stage and a prospective physician reader-study stage.
- Trial name
- NCT07829640
- Testing
- Chest CT Artificial Intelligence Decision-Support System
- Where
- China
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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.
Breast Cancer
Fujifilm Feature Comparison Reader Study to Compare Old vs New Processing
The purpose of the feature comparison study is to evaluate general mammographic features in images of the same breast when reconstructed with modified (ISR and DVIIm) processing as compared to the original processing (FBP with…
- Trial name
- NCT03586583
- Testing
- FBP, ISR
- Where
- United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, Inc.
Chronic Constipation
Effect of PEG, Bisacodyl and Prucalopride on Colonic Motility in Healthy Subjects
This study aim was to evaluate the effect of pharmacological treatments normally used to treat functional constipation and in particular PEG, bisacodyl and prucalopride on colonic motility as assessed by high-resolution manometry.
- Trial name
- NCT03279341
- Testing
- polyethylene glycol, Bisacodyl, Prucalopride
- Where
- Belgium
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University Hospital, Gasthuisberg
Retinal Disease
AI-Assisted Interpretation of Ultra-Widefield Retinal Images
The goal of this prospective observational study is to evaluate the impact of artificial intelligence (AI) assistance on clinician interpretation of ultra-widefield (UWF) retinal images.
- Trial name
- NCT07651943
- Testing
- AI-Assisted Interpretation, Unaided Interpretation
- Where
- 5 sites in China
- Volunteers
- 462 people, healthy volunteers welcome
- Sponsor
- Xiamen Ophthalmology Center Affiliated to Xiamen University
Breast Cancer
CRRS-4 Pivotal Somo•v™ ABUS ROC Reader Observer Study
To determine the impact on Interpreting Physician performance in detecting breast cancer, as defined by the area under the Receiver Operating Characteristic Curve (ROC), when Automated Breast Ultrasound (ABUS) and screening…
- Trial name
- NCT01424956
- Testing
- Automated Breast Ultrasound (ABUS)
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- U-Systems, Inc.
Functional Dyspepsia
Electrogastrogram (EGG) Reproducibility Study: EEG Readings in Normal Subjects and Dyspeptic Patients
The primary objective of this study is to determine whether EGG readings obtained from both normal subjects and dyspeptic patients are reproducible from one EGG recording to another on a different day.
- Trial name
- NCT00220883
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Temple University
Breast Cancer
Multi-Reader, Multi-Case, Cross-Over, Retrospective Study to Evaluate Effectiveness of Lunit INSIGHT DBT
This study aims to evaluate Effectiveness of Lunit INSIGHT DBT in the assistance of detection and diagnosis of breast cancer during 3D mammography interpretation
- Trial name
- NCT05716958
- Testing
- Digital Breast Tomosynthesis
- Where
- United States
- Volunteers
- 262 people, healthy volunteers welcome
- Sponsor
- Lunit Inc.
Breast Cancer
Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer - A Pivotal Study
The purpose of the pivotal reader study is to assess the comparative accuracy of Fujifilm DBT plus S-View versus FFDM in the detection of breast cancer.
- Trial name
- NCT03501693
- Testing
- DBT plus S-View, FFDM Alone
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, Inc.
Breast Cancer
Study to Evaluate Effectiveness of Investigational Device in the Assistance of Detection and Diagnosis of Breast Cancer
This study aims to evaluate Effectiveness of Investigational Device, Lunit INSIGHT MMG, in the assistance of Detection and Diagnosis of Breast Cancer during Screening Mammography Interpretation.
- Trial name
- NCT05615298
- Testing
- Mammography
- Where
- United States
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Lunit Inc.
Breast Cancer
Pilot 3D Mammography Reader Study to Assess Breast Cancer Detection in 3D Versus 2D Digital Mammography
The purpose of this pilot study is to provide credible performance estimate information in order to properly plan, design, and power a larger clinical study.
- Trial name
- 3DM (NCT01928992)
- Testing
- 3D, 2D
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, Inc.
Breast Cancer
Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Fujifilm FFDM and DBT Reader Training Program
The purpose of this pilot is to assess the adequacy of the Fujifilm DBT Reader Study Training program to ensure that Readers participating in the Fujifilm DBT pivotal trial are properly trained in the reading and interpretation…
- Trial name
- NCT02685566
- Testing
- FFDM Plus DBT, FFDM
- Where
- 5 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, Inc.
Breast Cancer
Pilot Mammography Reader Study to Assess Breast Cancer Detection in FFDM Plus DBT Versus FFDM Alone
The purpose of this pilot is to provide credible performance estimate information in order to conduct subsequent reader studies.
- Trial name
- NCT02511730
- Testing
- FFDM Plus DBT, FFDM
- Where
- 4 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, Inc.
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.
Catheters, With or Without Malposition, Image Interpretation, Computer Assisted
Reader Study to Demonstrate That Use of ClearRead Confirm is Superior to the Use Standard AP/PA X-ray Image
This is a study to determine whether or not a new type of software is, or is not, of benefit. The software, ClearRead Confirm, is designed to enhance the ability of radiologists to detect tubes, lines and wires that may be placed…
- Trial name
- NCT01655329
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Georgetown University
Congenital Heart Disease
Fetal Heart Ultrasound Suspicious Radiographic Finding Identification - Reader Study
Clinical performance of the device will be evaluated in a fully-crossed, multiple-reader multiple-case (MRMC) study. This study will be used to determine the impact of the device on reader performance in identifying suspicious…
- Trial name
- NCT06392555
- Testing
- Device-Aided performances, Device-Unaided performances
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- BrightHeart
Kidney Cancers, Prostate Cancer
Assessment of Intelligent Algorithms for Detection, Diagnosis and Risk Stratification of Tumors of the Kidney and Prostate
The COMFORT study will evaluate an artificial intelligence-based platform developed to support the clinical assessment of kidney and prostate cancer.
- Trial name
- COMFORT (NCT07888322)
- Testing
- Medical Reading, AI assisted Medical reading
- Where
- 6 sites in Germany, Greece and 2 more
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Aristotle University Of Thessaloniki
Pneumothorax, Intestinal Obstruction
The Impact of Artificial Intelligence-Assisted X-ray Interpretation on Radiologists' Diagnostic Performance
This study tests whether an artificial intelligence (AI) tool helps radiologists read X-rays more accurately. Radiologists read X-rays to find diseases such as pneumonia, bone fractures, and abdominal problems.
- Conditions
- Pneumothorax, Intestinal Obstruction, Spondylolysis, Renal Calculus
- Trial name
- NCT07870928
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- The Third Affiliated Hospital of Southern Medical University
Breast Cancer
Effectiveness of CadAI-B for Breast
The purpose of this study is to evaluate the effectiveness of lesion detection and diagnosis-aiding software (CadAI-B for Breast) during ultrasound (US) examination
- Trial name
- NCT06352684
- Testing
- CadAI-B for Breast
- Where
- South Korea
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- BeamWorks Inc.