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Primary Diagnosis Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System

NCT03991468 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2022-12-22

Study results available
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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.

Conditions

  • Pathology

Interventions

DIAGNOSTIC_TEST

Whole Slide Imaging

Scanning of a glass slide to create a digital image that can be viewed on a monitor

DIAGNOSTIC_TEST

Light Microscopy

Use of traditional light microscopy per institutional standard practice

Sponsors & Collaborators

  • Hamamatsu Photonics K.K.

    lead INDUSTRY

Principal Investigators

  • Liron Pantanowitz · University of Pittsburgh Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-15
Primary Completion
2021-07-31
Completion
2021-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03991468 on ClinicalTrials.gov