Trials / Completed
CompletedNCT03991468
Primary Diagnosis Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
Clinical Validation for Non-Inferiority of Primary Diagnosis by WSI Hamamatsu NanoZoomer S360MD Digital Slide Scanner System Compared to Conventional Determination by Light Microscope
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2,000 (actual)
- Sponsor
- Hamamatsu Photonics K.K. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2019-03-15
- Primary completion
- 2021-07-31
- Completion
- 2021-07-31
- First posted
- 2019-06-19
- Last updated
- 2022-12-22
- Results posted
- 2022-12-22
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03991468. Inclusion in this directory is not an endorsement.