A Prospective Multicenter Investigation of the da Vinci Xi Surgical System in Nipple Sparing Mastectomy (NSM) Procedures

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Study Overview

The goal of this prospective study is to evaluate the safety and effectiveness of the da Vinci Xi Surgical System, instruments, and accessories in Nipple Sparing Mastectomy, otherwise known as NSM procedures.

Study Description

The primary effectiveness endpoint will evaluate the ability of the da Vinci Xi to complete the NSM procedure without converting to an open approach and the ability to preserve the NAC during the 42-day follow-up period. The primary safety endpoint will evaluate the incidence of intraoperative NSM procedure and device-related adverse events and all post-operative adverse events that occur through the 42-day follow-up period as compared to the published rates reported for open NSM procedures.

  • Study Identifier: 834811

Recruitment Status

Open

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