Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
Study NCT ID:
NCT03992768
Status:
COMPLETED
Last Update Posted:
2022-12-22
First Post:
2019-06-18
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Feature Detection Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
Sponsor:
Hamamatsu Photonics K.K.
Organization:
Study Overview
Official Title:
Clinical Validation for Feature Detection Precision by WSI Using Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to evaluate the repeatability and reproducibility of detection of histological features using whole slide imaging
Detailed Description:
The study will be conducted under the following 3 sub-studies:
1. Scans within Scanner (Intra-scanner precision substudy),
2. Scanners within a site (Inter-scanner precision substudy),
3. Scanners between sites (Inter-site precision substudy)
1. Scans within Scanner (Intra-scanner precision substudy),
2. Scanners within a site (Inter-scanner precision substudy),
3. Scanners between sites (Inter-site precision substudy)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: