Evaluation of the Omnyx™ Integrated Digital Pathology System in the Primary Diagnosis of Surgical Pathology Specimens (PrimeDx)

March 24, 2016 updated by: Omnyx, LLC

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Omnyx™ IDP system
Omnyx™ IDP system for Whole Slide Images (WSI)
Other: Omnyx™ IDP system
Omnyx™ IDP system for Whole Slide Images (WSI)
Placebo Comparator: Conventional light microscope
conventional light microscope
Other: Conventional light microscope
Conventional light microscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis of surgical pathology
Time Frame: 1 Year
Demonstrate the effectiveness of the Omnyx™ IDP system is non-inferior to the Diagnostic Reference Standard glass diagnosis in routine surgical pathology cases.
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Omnyx, LLC

Investigators

  • Study Chair: Michael Montalto, PhD, Omnyx, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

June 4, 2015

First Submitted That Met QC Criteria

June 11, 2015

First Posted (Estimate)

June 12, 2015

Study Record Updates

Last Update Posted (Estimate)

March 28, 2016

Last Update Submitted That Met QC Criteria

March 24, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD-0010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Diagnosis of Surgical Pathology Specimens

Clinical Trials on Omnyx™ IDP system

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe