Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing Mastectomy

December 17, 2025 updated by: Intuitive Surgical

A Prospective, Multicenter Investigation of the da Vinci® Surgical Systems in Nipple Sparing Mastectomy (NSM) Procedures

This study evaluates the safety and effectiveness of the da Vinci Surgical Systems in prophylactic Nipple Sparing Mastectomy procedures.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

145

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Florida
    • Illinois
      • Evanston, Illinois, United States, 60201
        • NorthShore University Health System
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New York
      • New Hyde Park, New York, United States, 11040
        • Northwell Health
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • University of Pennsylvania
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 or subject has breast cancer in one breast and is seeking prophylactic NSM on contralateral side.
  • Breast ptosis ≤ Grade 2.
  • Cup size ≤ C.
  • No presence of occult cancer on the side for which she is seeking prophylactic NSM surgery 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 on the breast for which she is seeking prophylactic NSM surgery.
  • Previous breast surgery of the ipsilateral breast (excluding needle or core biopsies and excisional biopsies performed more than 1 year prior).
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nipple Sparing Mastectomy
Device: Nipple-Sparing Mastectomy
Nipple-sparing mastectomy using da Vinci Surgical Systems.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Safety: Incidence of adverse events
Time Frame: Assessed during surgery to 42 days after surgery
Incidence of intraoperative and post-operative procedure and device-related adverse events
Assessed during surgery to 42 days after surgery
Primary Effectiveness: No conversions to open NSM
Time Frame: Assessed during surgery
Conversion is defined as conversion of da Vinci robotic-assisted surgery to open surgery
Assessed during surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of breast cancer
Time Frame: Annual through 5 year post-operatively
Occurrence and recurrence of breast cancer
Annual through 5 year post-operatively
Patient reported outcomes
Time Frame: Pre-operatively, post-operatively at 42 days, annually through 5 years
BREAST-Q
Pre-operatively, post-operatively at 42 days, annually through 5 years
Long-term safety: incidence of adverse events
Time Frame: Annually through 5 years post-operatively
Incidence of breast procedure-related adverse events during long-term follow up
Annually through 5 years post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intuitive Surgical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2021

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

December 30, 2029

Study Registration Dates

First Submitted

March 21, 2019

First Submitted That Met QC Criteria

March 26, 2019

First Posted (Actual)

March 27, 2019

Study Record Updates

Last Update Posted (Estimated)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISI dV Xi-SP NSM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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