Prospective, multi-center, single-arm clinical study in females undergoing immediate implant-based breast reconstruction using a pre-pectoral technique
Females at least 22 years of age
Scheduled to undergo unilateral or bilateral mastectomy with immediate implant-based, prepectoral breast reconstruction
Willing to provide Informed Consent
Able to return for all required study visits
Is of childbearing potential and has a positive pregnancy test within 7 days of study procedure
Has a residual gross tumor at the intended reconstruction site
Has undergone previous breast surgery, such as lumpectomy or breast augmentation, at the site of implantation with the exception of a biopsy
Has undergone previous radiation therapy to the reconstruction site or chest wall, or is scheduled to undergo post-operative radiation therapy at the reconstruction site
Musculoskeletal Transplant Foundation
Lead sponsor
MCRA (an IQVIA business)
Collaborator
Bruder Consulting International, LLC
Collaborator