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:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT04260620
Eligibility Criteria:
Radiologists of any age, sex, race, ethnicity, or institutional affiliation may participate as study readers. All readers must meet the following base Inclusion Criteria:
* Hold a current United States medical license
* Be American Board of Radiology Certified
* Be MQSA-qualified
* Be experienced in reading DM images on a monitor
* Be experienced in reading Breast Ultrasound images on a monitor
* Have completed a Financial Disclosure showing no Conflicts of Interest
* Have provided a current curriculum vitae (CV)
* Have provided a signed Readers' Agreement
* Have provided written Informed Consent
All qualified and confirmed readers will complete a multi-module SoftVue™ training program prior to their participation in a reading session for this study.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04260620
Study Brief:
Protocol Section:
NCT04260620