Status:
COMPLETED
CRRS-4 Pivotal Somo•v™ ABUS ROC Reader Observer Study
Lead Sponsor:
U-Systems, Inc.
Conditions:
Breast Cancer
Eligibility:
All Genders
Brief Summary
To determine the impact on Interpreting Physician performance in detecting breast cancer, as defined by the area under the Receiver Operating Characteristic Curve (ROC), when Automated Breast Ultrasou...
Detailed Description
The Clinical Retrospective Reader Study is an observational case-controlled, multi-reader multi-case Receiver Operating Characteristic (ROC) study involving approximately 16 Interpreting Physicians (R...
Eligibility Criteria
Inclusion
- Interpreting Physician as defined under 21CFR §900.12(a)(1)(i)(B)(2).
- Fellowship-Trained in Breast Imaging and or have 10 years experience in breast imaging in which the radiologist's practice was at least 70% breast imaging
- Currently meets the minimum Mammography Interpretation requirements per MQSA
- Review Rate of at least 1,000 Mammograms annually for the year prior to study participation
- Review Rate of at least 500 Breast Ultrasounds annually for the year prior to study participation
- Successful completion of ABUS training
Exclusion
- Does not meet definition of Interpreting Physician as defined under 21CFR §900.12(a)(1)(i)(B)(2).
- Does not meet requirements of Fellowship-Trained in Breast Imaging and or have 10 years experience in breast imaging in which the radiologist's practice was at least 70% breast imaging
- Does not meet requirements of minimum Mammography Interpretation requirements per MQSA
- Does not meet requirements of Review Rate of at least 1,000 Mammograms annually for the year prior to study participation
- Does not meet requirements of Review Rate of at least 500 Breast Ultrasounds annually for the year prior to study participation
- Does not meet requirements of successful completion of ABUS training
Key Trial Info
Start Date :
July 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01424956
Start Date
July 1 2011
End Date
September 1 2011
Last Update
April 17 2013
Active Locations (1)
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1
U-Systems, Inc.
Sunnyvale, California, United States, 94085