This study evaluates the safety and effectiveness of the da Vinci Surgical Systems in prophylactic 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 Surgical Systems in NSM procedures.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
145
Nipple-sparing mastectomy using da Vinci Surgical Systems.
Mayo Clinic Florida
Jacksonville, Florida, United States
NorthShore University Health System
Evanston, Illinois, United States
Mayo Clinic
Rochester, Minnesota, United States
Northwell Health
New Hyde Park, New York, United States
Primary Effectiveness: No conversions to open NSM
Conversion is defined as conversion of da Vinci robotic-assisted surgery to open surgery
Time frame: Assessed during surgery
Primary Safety: Incidence of adverse events
Incidence of intraoperative and post-operative procedure and device-related adverse events
Time frame: Assessed during surgery to 42 days after surgery
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States