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 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT05424666
Eligibility Criteria:
Inclusion Criteria:
Female gender.
Age of 18 years and older.
History or in candidate for a mastectomy in the near future.
Patients undergoing prophylactic mastectomy.
Patients' choice to undergo a breast reconstruction.
Wanting to participate in this study.
Patient is able to wear the BRAVA (BRA like VAcuum-based external tissue expander) device.
Exclusion Criteria:
Active smoker or a history of smoking 4 weeks prior to surgery.
Current substance abuse.
History of lidocaine allergy.
Four weeks or less after chemotherapy.
History of radiation therapy in the breast region.
Oncological treatment includes radiotherapy after mastectomy.
Kidney disease.
Steroid dependent (daily or weekly).
Immune-suppressed or immune-compromised disease.
Uncontrolled diabetes.
body mass index of \>30.
Large breast size (ie, larger than cup C), unless the patient prefers reduction of the contralateral side towards cup C.
Extracapsular silicone leaking from the encapsulated implant from a previous breast reconstruction.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05424666
Study Brief:
Protocol Section:
NCT05424666