The purpose of this clinical study is to collect data about the use of a robotic device called the da Vinci Single-Port (SP) Surgical System in nipple-sparing mastectomy (NSM) procedures. NSM is a surgery for women intended to remove breast tissue from under the skin and the nipple due to cancer or as a preventative measure to reduce the risk of cancer. This study focuses on women who have early-stage breast cancer. The da Vinci SP Surgical System is designed for surgeons to perform minimally invasive surgery. Researchers will compare data between patients that have robotic-assisted NSM procedures and patients that have open NSM procedures. (The open NSM procedure is the same procedure patients would have if they chose not to participate in this study.) Data from the study will help determine whether the device is safe and effective for NSM procedures. The da Vinci SP Surgical System is currently allowed for use by the U.S. Food and Drug Administration (FDA) in other surgeries, but its use in this study is investigational.
What is the full name of this clinical trial?
ISIDVSP-NSM-01: A Prospective, Multicenter Randomized Controlled Trial of the da Vinci® SP Surgical System vs Open Surgery in Nipple Sparing Mastectomy Procedures.