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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT03456427
Eligibility Criteria:
Inclusion Criteria:
1. Are women aged 40 years or older;
2. Are asymptomatic and scheduled for screening mammography;
3. Have left and right breasts;
4. Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off;
5. Are documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy;
6. Are able and willing to comply with study procedures; and
7. Are able and willing to provide written informed consent to participate.
Exclusion Criteria:
1. Are women aged 40 years or older;
2. Are asymptomatic and scheduled for screening mammography;
3. Have left and right breasts;
4. Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off;
5. Are documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy;
6. Are able and willing to comply with study procedures; and
7. Are able and willing to provide written informed consent to participate.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Study:
NCT03456427
Study Brief:
Protocol Section:
NCT03456427