Ignite Creation Date:
2024-05-05 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00749255
Status:
TERMINATED
Last Update Posted:
2011-01-19
First Post:
2008-09-05
Brief Title:
Collect Breast Cancer Patients Digital Mammography Images With Corresponding Reports for the Development of Software
Sponsor:
WellSpan Health
Organization:
WellSpan Health
Study Overview
Official Title:
R2 Case Collection
Status:
TERMINATED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
not enough personnel to conduct study at site
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this case collection effort is software design by R2 Technologies Inc The information received from Womens Imaging will be provided to the Case Collection Data Management and Algorithmsoftware design and development teams who are responsible for the receipt of patient data and management of such data and creation testing and validation of R2 Technologies Inc for Computer Aided Detection CAD and new digital image archiving software design
Detailed Description:
The information is necessary for Sponsor development efforts and will be utilized as a viewing tool with supporting written documentation of the findings on each image itself The information will be used to develop algorithms that will foster development of CAD software The information in each image andor accompanying written clinical case documentation will not be analyzed in any way for clinical events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None