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Clinical Trials in the USA / NCT03892980
Active, not recruiting Not applicable

Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing Mastectomy

NCT03892980 · tracked via the Priya Life Science USA tracker
Sponsor
Intuitive Surgical
Phase
Not applicable
Started
2021-03-26
Last updated
2025-12-18

Condition(s) studied

Nipple Sparing Mastectomy

Investigational drug(s) / intervention(s)

Nipple-Sparing Mastectomy

Nipple-Sparing Mastectomy: Nipple-sparing mastectomy using da Vinci Surgical Systems.

Study summary

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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

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

Trial sites (6)

FacilityCityRegionStatus
Mayo Clinic Florida Jacksonville Florida
NorthShore University Health System Evanston Illinois
Mayo Clinic Rochester Minnesota
Northwell Health New Hyde Park New York
University of Pennsylvania Philadelphia Pennsylvania
MD Anderson Cancer Center Houston Texas

More Intuitive Surgical trials in the USA

Open Nipple Sparing Mastectomy (NSM) Active, not recruiting
A Study to Understand the Utility of the Force Feedback Instruments in Robotic Procedures Using da Vinci 5 Robot Active, not recruiting
Clinical Investigation of the da Vinci Surgical System Active, not recruiting
Real World Registry for Use of the Ion Endoluminal System Active, not recruiting
Robotic vs. Open NSM for Early Stage Breast Cancer Active, not recruiting

Other trials for the same condition

Open Nipple Sparing Mastectomy (NSM) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03892980 on ClinicalTrials.gov ↗ ← All trials in the USA