Primary Diagnosis Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
Public ClinicalTrials.gov record NCT03991468. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Clinical Validation for Non-Inferiority of Primary Diagnosis by WSI Hamamatsu NanoZoomer S360MD Digital Slide Scanner System Compared to Conventional Determination by Light Microscope
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03991468
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 2,000 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 14, 2019
- Primary completion
- Jul 30, 2021
- Completion
- Jul 30, 2021
- Last update posted
- Dec 21, 2022
2019 – 2021
United States locations
- U.S. sites
- 4
- U.S. states
- 3
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63110 | — |
| TriCore Reference Laboratories | Albuquerque | New Mexico | 87102 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| The Ohio State University | Columbus | Ohio | 43210-1063 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03991468, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 21, 2022 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03991468 live on ClinicalTrials.gov.