Primary Diagnosis of Surgical Pathology SpecimensPrimeDxNCT02470572
Evaluation of the Omnyx™ Integrated Digital Pathology System in the Primary Diagnosis of Surgical Pathology Specimens
A study testing Omnyx™ IDP system and Conventional light microscope in people with Primary Diagnosis of Surgical Pathology Specimens, run by Omnyx, LLC.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Diagnosis of Surgical Pathology Specimens
- What is being tested?
- Omnyx™ IDP system and Conventional light microscope
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All surgical pathology samples from pre-identified list provided by FDA
Who cannot join
- 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
About this study
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.
Read the 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
- Being tested
- Omnyx™ IDP system, Conventional light microscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omnyx™ IDP systemOther
Omnyx™ IDP system for Whole Slide Images (WSI)
Conventional light microscopeOther
Conventional light microscope
| Study group | Role | What they receive |
|---|---|---|
| Omnyx™ IDP system | Active comparator | Omnyx™ IDP system for Whole Slide Images (WSI) Receives: Other: Omnyx™ IDP system |
| Conventional light microscope | Placebo comparator | conventional light microscope Receives: Other: Conventional light microscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of surgical pathology
Demonstrate the effectiveness of the Omnyx™ IDP system is non-inferior to the Diagnostic Reference Standard glass diagnosis in routine surgical pathology cases.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Diagnosis of Surgical Pathology SpecimensStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Omnyx, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Montalto, PhD, Study chair, Omnyx, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470572
- Sponsor's protocol ID
- CD-0010
- Acronym
- PrimeDx
- Status last verified
- Mar 2016
- First submitted
- 4 Jun 2015
- Last updated
- 28 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Omnyx™ Integrated Digital Pathology System in the Primary Diagnosis of Surgical Pathology Specimens
- ClinicalTrials.gov ID
- NCT02470572
- Acronym / sponsor ID
- PrimeDx / CD-0010
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Omnyx, LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 12 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omnyx™ IDP system | Active comparator | Other: Omnyx™ IDP systemOmnyx™ IDP system for Whole Slide Images (WSI) |
| Conventional light microscope | Placebo comparator | Other: Conventional light microscopeconventional light microscope |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All surgical pathology samples from pre-identified list provided by FDA
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omnyx™ IDP systemOmnyx™ IDP system for Whole Slide Images (WSI) | Other | Omnyx™ IDP system |
| Conventional light microscopeConventional light microscope | Other | Conventional light microscope |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2016.
Related trials for Primary Diagnosis of Surgical Pathology Specimens
Active, not recruitingObservational study
Biological Sample Repository for Gastrointestinal Disorders
Obesity, Obesity, Morbid
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Montalto, PhD study chair
Omnyx, LLC
Questions about this trial
What is this clinical trial studying?
A study testing Omnyx™ IDP system and Conventional light microscope in people with Primary Diagnosis of Surgical Pathology Specimens, run by Omnyx, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of surgical pathology (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2016.