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NCT Number: NCT03892980

Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing Mastectomy

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Nipple Sparing Mastectomy

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Florida, Jacksonville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nipple-Sparing Mastectomy

Device

Nipple-sparing mastectomy using da Vinci Surgical Systems.

Primary outcomes

  1. 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

  2. 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

Other outcomes

  1. Incidence of breast cancer

    Time frame: Annual through 5 year post-operatively

    Occurrence and recurrence of breast cancer

  2. Patient reported outcomes

    Time frame: Pre-operatively, post-operatively at 42 days, annually through 5 years

    BREAST-Q

  3. 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

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2029
First posted
Mar 27, 2019
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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