Concordance Between Omnyx System With Omnyx .RTS Images and the Omnyx Dynamyx Software With Hamamatsu .NDPI Images

NCT04743843 | Completed

• 1 other identifier: CD-0042
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study serves as a validation study for the Omnyx Dynamyx software and Hamamatsu .ndpi image file format, evaluating agreement of diagnosis between whole slide images (WSI) of the Omnyx system (Omnyx scanned .rts images and Omnyx Dynamyx software) and the Omnyx Dynamyx software with the Hamamatsu .ndpi images. The primary goal of this study is to demonstrate concordance between the two systems to validate the Omnyx Dynamyx software with the non-Omnyx .ndpi image file type.

Conditions

Diagnoses Disease

Outcome Measures

Primary Outcomes (1)

• Concordance between digitized .rts images and digitized .ndpi images

  The proportion of diagnosis between Omnyx .rts images and Hamamatsu .ndpi images using Blyth-Still-Casella 95% confidence interval showed concordant diagnosis for each subspecialty and across all recommended subspecialties.

  3 months

Interventions

Omnyx Dynamyx Software DEVICE

Digital pathology image management and viewing software.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

• H\&Es, IHCs and Special stains available at the time of the original diagnosis

You may qualify if:

• Approximately 60 surgical pathology cases (20 from each sub-specialty group):
• Dermatopathology;
• Breast;
• Head and Neck • Slides that are no more than 2 years old

You may not qualify if:

• Frozen sections; and
• Cytology cases
• Slides that require special non-brightfield optical considerations such as polarization or fluorescence
• Hematology slides
• Slides that require 60x or higher magnification (oil immersion)

Sponsors & Collaborators

• Inspirata Europe Ltd.: lead

Study Sites (1)

Northern Lincolnshire and Goole NHS Foundation Trust

Lincoln, LN2 5QY, United Kingdom

Location

Study Officials

• Mark Lloyd, Ph.D.

  Inspirata, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 8, 2021
• Study Start: January 22, 2019
• Primary Completion: November 15, 2019
• Study Completion: November 15, 2019
• Last Updated: February 8, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)