Clinical trials: Reader Study
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.
Fractures, Musculoskeletal
Enhancing Diagnostic Accuracy in Fracture Identification on Musculoskeletal Radiographs Using Deep Learning
This retrospective study aims to evaluate the effectiveness of artificial intelligence (AI) in identifying fractures on musculoskeletal X-rays.
- Trial name
- NCT06644391
- Testing
- Carebot AI Bones
- Where
- Czechia
- Volunteers
- 600 people
- Sponsor
- Carebot s.r.o.
Breast Cancer
Imagio Feasibility Multi-Reader, Multi-Case Study
Controlled, blinded, multi-reader, multi-case study
- Trial name
- NCT03708393
- Testing
- Imagio (IUS+OA), Imagio Ultrasound, Mammography
- Where
- United States
- Volunteers
- 155 people
- Sponsor
- Seno Medical Instruments Inc.
Skin Lesions, Melanocytic Nevi
Evaluating an Artificial Intelligence Tool to Help Primary Care Doctors Diagnose Skin Conditions.
This study aims to determine if an artificial intelligence (AI) medical device can help primary care doctors more accurately identify and manage various skin conditions.
- Conditions
- Skin Lesions, Melanocytic Nevi, Melanoma (Skin Cancer), Basal Cell Carcinoma of Skin
- Trial name
- LegitHealth PH (NCT07428941)
- Testing
- AI-based medical device for aided diagnosis in dermatological conditions
- Where
- Spain
- Volunteers
- 9 people
- Sponsor
- AI Labs Group S.L
Pneumothorax, Pulmonary Nodule, Solitary
Multi-Reader Retrospective Study Examining Carebot AI CXR 2.0.21-v2.01 Implementation in Everyday Radiology Clinical Practice
The primary objective is to evaluate the performance parameters of the proposed DLAD (Carebot AI CXR) in comparison to individual radiologists.
- Conditions
- Pneumothorax, Pulmonary Nodule, Solitary, Atelectasis, Subcutaneous Emphysema
- Trial name
- NCT05963945
- Testing
- Carebot AI CXR
- Where
- Czechia
- Volunteers
- 956 people
- Sponsor
- Carebot s.r.o.
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.
Pregnancy
Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring and Nonlaboring Patients by Practicing Clinicians
This multi-reader multi-case study was designed to evaluate the performance of SureCALL® Labor Monitor® (SureCALL®) directly to the standard Tocodynamometer device (TOCO).
- Trial name
- NCT01730963
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Reproductive Research Technologies, LP
Stenosis
Magnevist® Injection Enhanced MRA Compared to Non Contrast MRA for the Detection of Stenosis in the Calf and/or Pedal Arteries
The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Magnevist (the study drug) used for MRI of the calf and foot arteries.
- Trial name
- NCT00309075
- Testing
- Gadopentetate dimeglumine (Magnevist)
- Volunteers
- 126 people
- Sponsor
- Bayer
Bowel Cleansing Prior to Clinical Procedures
A Study to Investigate Bowel Cleansing With PLENVU® Compared to Sodium Picosulfate in Participants Aged 1 to < 18 Years of Age in Preparation for Colonoscopy
The purpose of the study is to assess the efficacy, safety and tolerability of PLENVU® by measuring its bowel cleansing success rate compared to sodium picosulfate in paediatric participants aged less than 18 years who are…
- Trial name
- CLARITY (NCT07218523)
- Testing
- PLENVU®, Sodium picosulfate
- Where
- 46 sites in Belgium, Croatia and 8 more
- Volunteers
- 212 people
- Sponsor
- Norgine
Breast Cancer Detection, Dense Breast Parenchyma
Delphinus SoftVue™ ROC Reader Study
The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in…
- Conditions
- Breast Cancer Detection, Dense Breast Parenchyma, Benign Breast Findings, Normal Breast Screening
- Trial name
- DMT SV RRS2 (NCT03972605)
- Testing
- Reading of Automated Breast Ultrasound in conjunction with Screening Mammography
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Delphinus Medical Technologies, Inc.
Alzheimer Disease
A Reader Study to Assess Accuracy and Reliability of Flortaucipir F 18 Positron Emission Tomography (PET) Scan Interpretation
This study will evaluate the performance of physician readers trained to read flortaucipir-PET (positron emission tomography) scans.
- Trial name
- NCT03901092
- Testing
- flortaucipir F 18
- Where
- United States
- Volunteers
- 242 people
- Sponsor
- Avid Radiopharmaceuticals
Alzheimer's Disease
The Feasibility of Florbetapir Quantitation in Europe
This study will evaluate whether the addition of quantitation as an adjunct to visual interpretations significantly improves the accuracy of Amyvid scan interpretation.
- Trial name
- NCT02107599
- Testing
- Florbetapir (18F)
- Where
- Netherlands
- Volunteers
- 96 people
- Sponsor
- Avid Radiopharmaceuticals
Pustular Psoriasis (PP), Generalized Pustular Psoriasis (GPP)
Evaluating Legit.Health Plus Support for Improving Diagnosis of Generalized Pustular Psoriasis and Other Skin Conditions Among Primary Care Physicians and Dermatologists
This study aims to determine if an artificial intelligence (AI) medical device can help healthcare professionals more accurately diagnose rare and complex skin conditions.
- Conditions
- Pustular Psoriasis (PP), Generalized Pustular Psoriasis (GPP), Eczema Atopic Dermatitis, Acute Generalized Exanthematous Pustulosis
- Trial name
- LegitHealth BI (NCT07428915)
- Testing
- AI-based medical device for aided diagnosis in Dermatology
- Where
- Spain
- Volunteers
- 15 people
- Sponsor
- AI Labs Group S.L
Breast Cancer, Breast Neoplasms
Effectiveness of CadAI-B Dx for Decision Support in Breast Ultrasound
This is a retrospective, fully-crossed, multi-reader, multi-case (MRMC) study to evaluate the effectiveness of 'CadAI-B Dx' (CadAI-B) for decision support in breast ultrasound.
- Trial name
- NCT07287111
- Testing
- CadAI-B Dx
- Where
- South Korea
- Volunteers
- 797 people
- Sponsor
- BeamWorks Inc.
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.
Cardiovascular Abnormalities
Magnevist® Injection Enhanced MRA Compared to Non Contrast MRA for the Detection of Structural Abnormalities of the Aortic Arch and Cerebral Branches
The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Magnevist (the study drug) used for MRI of the aortic arch and cerebral branches.
- Trial name
- NCT00310609
- Testing
- Gadopentetate dimeglumine (Magnevist)
- Volunteers
- 123 people
- Sponsor
- Bayer
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
Optoacoustic Images Versus Imagio® Ultrasound
The Imagio® Pivotal Study is intended to evaluate if the results observed in the previous Feasibility Study can be confirmed for pre-specified effectiveness endpoints.
- Trial name
- Reader-02 (NCT04030104)
- Testing
- Reader Study - Imagio Ultrasound, Reader Study Imagio Ultrasound + Optoacoustic Imaging, Mammography
- Where
- United States
- Volunteers
- 480 people
- Sponsor
- Seno Medical Instruments Inc.
Influenza
"Quidel Reader Influenza A + B Test 510(k) and CLIA Waiver Field Study"
The objective of this study is to demonstrate the clinical performance of the Quidel Reader Influenza A+B test and Quidel Reader with the following sample types: nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash.
- Trial name
- NCT01309568
- Where
- 16 sites in United States
- Volunteers
- 2,500 people
- Sponsor
- Quidel Corporation