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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT05408260
Eligibility Criteria:
Inclusion Criteria:
* Female
* \>= 18 years of age at time of consent
* Free of focal breast symptoms and with no suspicious breast physical exam findings
* Previous unilateral NSM or SSM with implant (silicone, saline) or flap reconstruction performed at Thomas Jefferson University Hospital
* Must be able to understand and provide signed and dated informed consent form. If a patient understands the informed consent but is unable to sign, a legally authorized representative (LAR) may sign
* Willing to comply with all study procedures and be available for the duration of the study
* Willing to honor any bills that may be incurred if the insurance company does not pay for the billed bilateral hand held ultrasound
Exclusion Criteria:
* History of breast cancer recurrence
* Current focal breast symptoms since NSM or SSM with reconstruction
* NSM or SSM with reconstruction was performed years prior to study enrollment
* Bilateral NSM or SSM with reconstruction
* Females who are pregnant
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05408260
Study Brief:
Protocol Section:
NCT05408260