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 @ 2:39 PM
Ignite Modification Date:
2025-12-24 @ 2:39 PM
NCT ID:
NCT04716959
Eligibility Criteria:
Inclusion Criteria:
* Women aged 21-60 years
* Planning to undergo immediate two stage prosthetic breast reconstruction with TE placement as the first stage.
* Planning to undergo unilateral or bilateral mastectomy.
* Planning to undergo nipple- or skin-sparing mastectomy.
* Mastectomy weight less than 800 grams.
* Adequate mastectomy skin perfusion or patients with adequate perfusion but nonviable mastectomy skin that can be excised (≤ 4 cm) at the defect margins with otherwise adequate perfusion.
Exclusion Criteria:
* Receipt of neoadjuvant chemotherapy for locally advanced breast cancer.
* Presence of preoperative axillary lymph node metastasis.
* Presence of intraoperative sentinel node positivity.
* History of radiotherapy.
* Current smoker.
* Planning to undergo direct-to-implant reconstruction.
* BMI \>35.
* Prior sternotomy.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
60 Years
Study:
NCT04716959
Study Brief:
Protocol Section:
NCT04716959