Robotic-Assisted da Vinci Xi Nipple-Sparing Mastectomy
Robotic-Assisted da Vinci Xi Nipple-Sparing Mastectomy
This study evaluates the safety and effectiveness of the da Vinci Xi Surgical System in
 Nipple Sparing Mastectomy procedures.
Surgical management for breast cancer and risk-reducing techniques have evolved from radical
 mastectomy to other techniques such as nipple and skin sparing procedures. Nipple-sparing
 mastectomy (NSM) with reconstruction technology offers the opportunity to preserve the shape
 of both the breast and the nipple-areola complex.

 This study will evaluate the safety and effectiveness of the da Vinci Xi Surgical System in
 NSM procedures.
Inclusion Criteria:

 -  Female between ages 18-80.

 -  BMI ≤ 29.

 -  Candidate for an NSM procedure.

 -  At increased risk for breast cancer and is seeking prophylactic NSM surgery.

 -  Breast ptosis ≤ Grade 2.

 -  Cup size ≤ C.

 -  No presence of occult cancer as confirmed by physical exam and by preoperative imaging
 per institution's guidelines.

 Exclusion Criteria:

 -  Current or prior history of ipsilateral in-situ or invasive breast carcinoma.

 -  Previous breast surgery of the ipsilateral breast

 -  Current history of smoking or has smoked within 1 year of screening.

 -  Skin conditions

 -  Uncontrolled diabetes mellitus.

 -  Previous chemotherapy or radiation

 -  High risk for anesthesia or significant medical comorbidities

 -  Contraindicated for general anesthesia or surgery.

 -  Known bleeding or clotting disorder.

 -  Pregnant or suspected to be pregnant or is lactating.