Instrument Precision Study for Validation of Philips Dx

NCT02699970 | Completed Results

• 1 other identifier: DPS-CT-0009
• Study Type: observational
• Target: 399
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate precision of the Philips Dx system.

Conditions

Pathology

Outcome Measures

Primary Outcomes (1)

• Agreement Rate

  The agreement rate between reads calculated over all selected features and pathologists. Readings were considered in agreement when the selected feature was indicated as 'present' or 'absent' in both readings.

  2 months

Study Arms (1)

Selected features

No intervention is administered to the selected features. They only need to be observed by the pathologist. The features are part of tissue that is present on a slide. This slide is fully scanned and the digital image is than viewed by the pathologist who indicates if he can see the feature. By repeating the scan three times and having the pathologist view three times, the consistency of the feedback can be monitored. The consistency is a measure on how repeatable and reproducible the scanner is. To be very clear: the scanner does not do anything to the tissue. It only takes a digital 'photo' of the tissue. It is no treatment or intervention. It just takes a picture.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cases will be selected from the LIS in consecutive order. Cases will be selected per feature and per organ. From these cases, slides will be selected containing the pre-specified study feature.

You may qualify if:

• Left-over specimens from subjects who already received their diagnosis and have received their treatment in accordance with the standard of care
• H\&E glass coverslipped slides with human tissue obtained via surgical pathology
• Selected slides fulfill the quality checks according to the Instructions for Use (lfU)
• Selected slides must be between 1-5 years since accessioning
• Selected slides and FOVs must contain a study feature that is: In it's natural environment (on slide and FOV); Readily observable (on slide and FOV); Not equivocal (on slide and FOV).

You may not qualify if:

• Selected slides contain indelible markings
• Selected slides contain damaged tissue
• More than one slide was selected for a patient (only one slide may be enrolled per patient).

Sponsors & Collaborators

• Philips Digital & Computational Pathology: lead

Study Sites (1)

MGH

Boston, Massachusetts, 02114, United States

Location

Results Point of Contact

• Title: Mischa Nelis, Clinical Study Director
• Organization: Philips Digital Pathology Solutions

dpsclinicaltrials@philips.com

Study Officials

• Mischa Nelis

  Philips DPS

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: March 7, 2016
• Study Start: February 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 1, 2019
• Results First Posted: November 1, 2019

Record last verified: 2019-10

Locations

US (1)