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:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2025-12-24 @ 2:43 PM
NCT ID:
NCT05975359
Eligibility Criteria:
Inclusion Criteria:
1. Breast cancer diagnosis (any form) or Genetic mutation with presence of breast mass.
2. Indication for bilateral mastectomy
3. Plan for immediate, implant-based pre-pectoral breast reconstruction using an acellular dermal matrix
4. Age 18 - 65
5. Female Sex
6. Ability to understand and the willingness to personally sign the written IRB-approved informed consent document (English language).
Exclusion Criteria:
1. Have a prior history of radiation to the breast or planned radiotherapy to the breast within the first year post-operatively.
2. Are enrolled in another study that requires the concomitant use of any investigational product during the study period that the Principal Investigator believes will interfere with study endpoints.
3. Have received oncologic chemotherapy within the past 21 days or planned within the time fame of the study intervention. Have received antiplatelet therapy (other than aspirin) and/ or other anticoagulation therapy in the past 60 days.
4. Are a smoker or use illicit drugs.
5. Any prior allergic reaction to Teflon.
6. Are pregnant or nursing.
7. Are undergoing a delayed reconstruction following mastectomy.
8. HIV infection, active UTI infection, or other active infection.
9. Those requiring more than one Manifold for fluid removal per breast will be excluded.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05975359
Study Brief:
Protocol Section:
NCT05975359