Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing Mastectomy

NCT03892980 | Active Not Recruiting FDA Device

• 1 other identifier: ISI dV Xi-SP NSM
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Nipple Sparing Mastectomy

Keywords

breast; robot; robotic; nipple sparing mastectomy; NSM; da Vinci; surgery; mastectomy; prophylactic NSM; risk reducing; BRCA mutation; nipple areola complex; NAC; RNSM; high-risk genetic mutation; gene mutation

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness: No conversions to open NSM

  Conversion is defined as conversion of da Vinci robotic-assisted surgery to open surgery

  Assessed during surgery

• Primary Safety: Incidence of adverse events

  Incidence of intraoperative and post-operative procedure and device-related adverse events

  Assessed during surgery to 42 days after surgery

Other Outcomes (3)

• Incidence of breast cancer

  Annual through 5 year post-operatively

• Patient reported outcomes

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

• Long-term safety: incidence of adverse events

  Annually through 5 years post-operatively

Study Arms (1)

Nipple Sparing Mastectomy

EXPERIMENTAL

Device: Nipple-Sparing Mastectomy

Interventions

Nipple-Sparing Mastectomy DEVICE

Nipple-sparing mastectomy using da Vinci Surgical Systems.

Nipple Sparing Mastectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intuitive Surgical: lead

Study Sites (6)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

NorthShore University Health System

Evanston, Illinois, 60201, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Northwell Health

New Hyde Park, New York, 11040, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Mastectomy, Subcutaneous

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects undergo nipple-sparing mastectomy (NSM) procedures using the da Vinci Surgical Systems

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 27, 2019
• Study Start: March 26, 2021
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 30, 2029
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)