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 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT02633605
Eligibility Criteria:
Inclusion Criteria:
* Female, over the age of 18 years of age.
* Asymptomatic women and women who are being screened for breast abnormality.
* Women scheduled for a mammogram or women who have had a mammogram and are given 3 days to wait in between their mammogram and scheduled biopsy and FS/TS system.
* Not pregnant or breast feeding.
* Signed Informed consent.
Exclusion Criteria:
* Subject does not meet inclusion criteria, noted above.
* Use of niacin or niacin patch.
* Use of nitroglycerin.
* Subject experienced a fever of 102°F or higher within thirty-six (36) hours of the study.
* Patients with any prior breast surgery (implants, reduction, lumpectomy, mastectomy, mastopexy, reconstruction and incisional biopsies.).
* History of breast cancer
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02633605
Study Brief:
Protocol Section:
NCT02633605