This study is looking at new ways to improve breast reconstruction surgery after a mastectomy (removal of the breast). Researchers are developing special 3D-printed breast molds designed to help surgeons shape tissue more efficiently during reconstruction using your own body tissue (autologous reconstruction). You might receive standard reconstruction care, or your surgeon might use one of these custom breast molds during your surgery. The main goal is to check the safety of these molds and any side effects. You may be able to join if you are 18 or older, can give informed consent, and are scheduled for breast reconstruction using a DIEP or TRAM flap (types of autologous reconstruction). This study plans to enroll 160 participants, but its current status is unclear.

Study design

This interventional study plans to enroll 160 participants. It compares standard reconstruction care with reconstruction where a custom breast mold may be used by the surgeon.

What's involved

You would undergo surgery for breast reconstruction. The study will assess safety and side effects for about one year after your surgery.

Compensation

Not stated in the trial record.

Follow-up

Your safety and any adverse events will be monitored through study completion, which is an average of one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.