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 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT04060134
Eligibility Criteria:
Inclusion Criteria:
* Female patient who underwent immediate breast reconstruction post-mastectomy; either direct to implant or with a tissue expander followed by exchange for a saline or gel implant.
* HADMs such as: InteguPly, SimpliDerm, AlloDerm, FlexHD, DermACELL, Cortiva, or AlloMax used in the breast reconstruction.
Exclusion Criteria:
* Female patient who underwent cosmetic/aesthetic breast augmentation procedure or revision.
* Female patient who underwent delayed breast reconstruction procedure.
* Female patient who underwent revision of previous breast reconstruction procedure.
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT04060134
Study Brief:
Protocol Section:
NCT04060134