Standalone Observational Study Assessing the Performance of an AI/ML Tech-based SaMD on Chest LDCT Images (REALITY)

CompletedOBSERVATIONAL
Enrollment

1,147

Participants

Timeline

Start Date

September 21, 2022

Primary Completion Date

July 24, 2024

Study Completion Date

August 21, 2024

Conditions
High Risk Cancer
Interventions
DEVICE

Median LCS

End-to-end processing of chest LDCT DICOM images by an AI/ML tech-based SaMD to detect, localize, and characterize (assign a malignancy score) each detected pulmonary nodule. The output of the device is a DICOM File (Median LCS result report) summarizing results per patient.

Trial Locations (5)

19104

University of Pennsylvania - Penn Center for Innovation, Philadelphia

28040

Fundacion instituto de investigacion sanitaria de la fundacion jimenez diaz (FJD), Madrid

31009

Universidad de Navarra, Pamplona

38120

Baptist Clinical Research Institute, Memphis

77030

The University of Texas M.D. Anderson Cancer Center, Houston

Sponsors
All Listed Sponsors
lead

Median Technologies

INDUSTRY