Robotic vs. Open NSM for Early Stage Breast Cancer

A Prospective, Multicenter Randomized Controlled Trial(RCT) of the da Vinci® SP™ Surgical System vs Open Surgery in Nipple Sparing Mastectomy (NSM) Procedures

This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.

This study is a prospective, two-arm, multi-center, randomized controlled clinical investigation between RSNM and open NSM.

This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.

Inclusion Criteria:

• Female age 21 or older
• BMI < 30
• Candidate for an NSM procedure with immediate reconstruction
• Diagnosis of early stage brest cancer
• Breast ptosis ≤ Grade 2.
• Cup size ≤ C.

Exclusion Criteria:

• Previous breast surgery
• Diagnosis of metastatic breast cancer
• Prior radiation treatment to the chest
• Current smokers
• Contraindication for general anesthesia or surgery.
• Known bleeding or clotting disorder.
• Pregnant or suspected to be pregnant, or actively breastfeeding