Image Evaluation of Philips Philips MammoDiagnost DR Full Field Digital Mammography System (FFDM)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Philips Healthcare

ClinicalTrials.gov Identifier:

NCT00999596

First received: October 21, 2009

Last updated: November 30, 2012

Last verified: November 2012

History of Changes

Results First Received: June 14, 2011

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Condition:	Breast Cancer

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment was initiated at out primary Diagnostic site in April 2010 and concluded in February 2011. A total of 35 diagnostic cases were obtained. Recruitment was initiated at out primary Screening site in May 2010 and concluded in November 2011. A total of 67 screening cases were obtained.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The trial was to evaluate performance of a FFDM system. During image acquisition FDA modified the trial criteria from an efficacy trial to a SE trial. Images from our diag site prior to Nov could not be used in this study as mag views were now required. Mag views were acquired in Jan-Feb 2011. Selected images were used from our screen site.

Reporting Groups

	Description
FFDM (Full Field Digital Mammography)	Mammograms from the Philips Digital System

Participant Flow: Overall Study

	FFDM (Full Field Digital Mammography)
STARTED	107
New FDA Guideline Released	6 ^[1]
COMPLETED	6 ^[2]
NOT COMPLETED	101
Statistical population not required	101

[1]	FDA Guidance: Class II Special Controls Guidance Document: Full-Field Digital Mammography System
[2]	Not all patient images were used for the reader evaluation based on new FDA Guidelines

Baseline Characteristics

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Reporting Groups

	Description
FFDM (Full Field Digital Mammography)	Mammograms from the Philips Digital System

Baseline Measures

	FFDM (Full Field Digital Mammography)
Number of Participants [units: participants]	107
Age [units: participants]
<=18 years	0
Between 18 and 65 years	107
>=65 years	0
Gender [units: participants]
Female	107
Male	0
Region of Enrollment [units: participants]
United States	104
Germany	3

Outcome Measures

1. Primary:

FFDM (Full Field Digital Mammography) Mammogram Scores [ Time Frame: Day 1 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Change in requirements from FDA modified the reading study per the Nov 5, 2010 FDA Guideline for FFDM.

Results Point of Contact:

Name/Title: Sarah Baxter or Linda Jalbert
Organization: Philips Healthcare
phone: 425-487-7665 / 978-659-7434
e-mail: sarah.baxter@philips.com, linda.jalbert@philips.com

No publications provided

Responsible Party:	Philips Healthcare
ClinicalTrials.gov Identifier:	NCT00999596 History of Changes
Other Study ID Numbers:	PMSDR-2008-002 & 2010-002
Study First Received:	October 21, 2009
Results First Received:	June 14, 2011
Last Updated:	November 30, 2012
Health Authority:	United States: Institutional Review Board

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