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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT00957567
Eligibility Criteria:
3.1 Eligibility Criteria All subjects will be women at least 35 years of age that have been found, after diagnostic workup, to have focal distributions of microcalcifications (BI-RADS 3, 4 or 5), focal soft tissue lesions (BI-RADS 3, 4 or 5), or no findings (BI-RADS 1).
3.2 Ineligibility Criteria
* Subject does not meet any of the inclusion criteria
* Women with suspected or confirmed pregnancy
* Women who have had bilateral mastectomy
* Women with large breasts that cannot be accommodated within the field of view of the tomosynthesis system
* Women who are very frail and unable to cooperate
* Women who are under 35 years of age
* Women who cannot give informed consent
* Male subjects
* Women with implants
* Subject has had breast augmentation, except for unilateral augmentation done for prior mastectomy
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
35 Years
Study:
NCT00957567
Study Brief:
Protocol Section:
NCT00957567