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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT06643767
Eligibility Criteria:
Inclusion Criteria:
1. Women who present to receive a screening mammogram.
2. Women of all races, ethnicities, and socio-economic backgrounds.
3. Signed informed consent obtained prior to any study assessments and procedures.
4. Age 30-75 years of age and female.
Exclusion Criteria:
1. Women with findings that are \< 0.5 cm or \> 3.5 cm
2. Palpable lesion (to the participant)
3. Positive clinical findings that cause a visible and obvious deformity of the breast or alteration in the skin appearance of the breast.
4. Women with breast tenderness significant enough to prevent completion of any of the study examinations. (Both ultrasound and Bexa require a light degree of pressure on the breast; certain women, very few, have enough breast tenderness that they cannot tolerate the pressure of either Bexa or ultrasound. Mammograms exert substantially more pressure on the breast.)
5. Women with breast significant skin scarring enough to prevent effective BBE (e.g., keloid scarring of the breast, for example), because extensive, hard surface scarring introduces artifact in the Bexa exam. Participant exclusion will be determined by the Bexa examiner.
6. Greater than 3 positive findings in a given breast.
7. Women who are unable to comprehend or unwilling to sign an informed consent form.
8. Women ages \< 30 and \> 75 years of age.
9. Pregnant women.
10. Women who have had a mastectomy - unilateral or bilateral.
11. Women who have had a recent (past 30 days) biopsy performed.
12. Women who have had a prior history of breast cancer in either breast.
13. Women who have had radiation to the breast.
14. Women who have had any breast surgery within the last 12 months.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT06643767
Study Brief:
Protocol Section:
NCT06643767