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 @ 1:00 PM
Ignite Modification Date:
2025-12-24 @ 1:00 PM
NCT ID:
NCT02263261
Eligibility Criteria:
Inclusion Criteria:
* Scheduled to undergo a single or two-stage, tissue-assisted, implant breast reconstruction
* Mastectomy may be unilateral or bilateral, prophylactic or therapeutic
* Skin incision may be skin sparing, or nipple-areolar sparing
* Have signed written, informed consent
* Be at least 18 years of age
Exclusion Criteria:
* Patients undergoing autologous breast reconstruction
* Patients undergoing breast reconstruction following complications of breast augmentation, mastopexy, breast reduction, or breast conservation surgery (lumpectomy)
* Patients undergoing reconstruction after previously failed attempts at reconstruction
* Patients undergoing autologous breast reconstruction in conjunction with a tissue expander (such as a latissimus dorsi flap, DIEP flap)
* There will be no exclusions based on race or ethnicity
* BMI \> 40
* Previous Radiation Treatment. Note: Post-operative radiation treatment does not exclude subjects from study continuation once enrolled.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02263261
Study Brief:
Protocol Section:
NCT02263261