Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT01424956
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT01424956
Study Brief:
Protocol Section:
NCT01424956