At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Validation for Non-Inferiority of Primary Diagnosis by WSI Hamamatsu NanoZoomer S360MD Digital Slide Scanner System Compared to Conventional Determination by Light Microscope
In Brief
A clinical study evaluating Whole Slide Imaging and Light Microscopy for Pathology. Completed, enrolled 2,000 participants across 4 sites.
Detailed Summary
The primary objective of this study is to evaluate the safety and accuracy of the Hamamatsu WSI compared to those of the reference method (conventional light microscope (Glass)) under clinical use conditions as an aid for pathologists to view, review and diagnose digital images of surgical pathology slides. The primary endpoint is the indicator of major discordance in primary diagnosis between ground truth case diagnosis and case diagnosis by each modality, WSI and Glass, separately.
Study Details
Timeline
Interventions
Scanning of a glass slide to create a digital image that can be viewed on a monitor
Use of traditional light microscopy per institutional standard practice