This trial is active, not recruiting.

Condition primary diagnosis of surgical pathology specimens
Treatments omnyx™ idp system, conventional light microscope
Sponsor Omnyx, LLC
Start date June 2015
End date March 2016
Trial size 1000 participants
Trial identifier NCT02470572, CD-0010


A multi-site, randomized-read order, retrospective, paired-design evaluation of the Omnyx™ Integrated Digital Pathology (IDP) system with de-identified and previously signed-out cases from all major organ systems. Pathologist will read and diagnose cases on a conventional light microscope and on the Omnyx™ IDP system for Whole Slide Images (WSI) with a randomized read order. College of American Pathologists (CAP) cancer protocol checklists will be used to capture diagnostic reporting.

Diagnoses rendered by site Reading Pathologists will be captured on CAP checklists and compared directly to the Ground Truth (GT) diagnosis for both modalities.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose diagnostic
(Active Comparator)
Omnyx™ IDP system for Whole Slide Images (WSI)
omnyx™ idp system
Omnyx™ IDP system for Whole Slide Images (WSI)
(Placebo Comparator)
conventional light microscope
conventional light microscope
Conventional light microscope

Primary Outcomes

Diagnosis of surgical pathology
time frame: 1 Year

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: • All surgical pathology samples from pre-identified list provided by FDA Exclusion Criteria: - Gross evaluation only specimens (including hardware and specimens that do not require microscopic review for diagnosis) - Immunofluorescence specimens - Fluid-based specimens - Intraoperative consultation specimens only (frozen preparation) - Specimens from which a slide(s) fails quality control according to user manuals and training and issue(s) cannot be remediated at the time of procurement and over-labeling; this includes having too many labels such that slide damage or scanner failure is likely (as outlined in Omnyx user manuals). - Specimens for which any slide (other than a blank) that should be in the case part cannot be located

Additional Information

Official title Evaluation of the Omnyx™ Integrated Digital Pathology System in the Primary Diagnosis of Surgical Pathology Specimens
Description Following the FDA issued guidance document, "Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable"- 2006, the specimens are surgical pathology samples from leftover human specimens from clinical cases, archived and previously signed-out across the majority of surgical pathology subspecialties
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Omnyx, LLC.