Robotic vs. Open NSM for Early Stage Breast Cancer (SP NSM)

A Prospective, Multicenter Randomized Controlled Trial(RCT) of the da Vinci® SP™ Surgical System vs Open Surgery in Nipple Sparing Mastectomy (NSM) Procedures

This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer; Breast Cancer Female; Breast; Breast Disease; Breast Cancer, Early-Onset
• Intervention / Treatment: Device: Robotic NSM; Procedure: Open NSM

Detailed Description

This study is a prospective, two-arm, multi-center, randomized controlled clinical investigation between RSNM and open NSM.

This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.

• Study Type: Interventional
• Enrollment (Estimated): 204
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92618
      • City of Hope
    • Los Angeles, California, United States, 940048
      • Cedars-Sinai
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Emory University
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Endeavor Health
  • Michigan
    • Detroit, Michigan, United States, 48073
      • Corewell
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic Rochester
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University, St. Louis
  • New York
    • Lake Success, New York, United States, 11042
      • Northwell Health
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • University of Pennsylvania
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53211
      • Ascension St. Columbia Mary's

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female age 21 or older
• BMI < 30
• Candidate for an NSM procedure with immediate reconstruction
• Diagnosis of early stage brest cancer
• Breast ptosis ≤ Grade 2.
• Cup size ≤ C.

Exclusion Criteria:

• Previous breast surgery
• Diagnosis of metastatic breast cancer
• Prior radiation treatment to the chest
• Current smokers
• Contraindication for general anesthesia or surgery.
• Known bleeding or clotting disorder.
• Pregnant or suspected to be pregnant, or actively breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic NSM with da Vinci SP; Subjects randomized to this arm will undergo robotic NSM (RNSM) procedures	Device: Robotic NSM; Robotic-assisted Nipple sparing mastectomy procedures; Other Names: RNSM; SP NSM
Active Comparator: Open NSM; Subjects randomized to this arm will undergo conventional open NSM procedures	Procedure: Open NSM; open nipple-sparing mastectomy procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conversion rate	Conversion is defined as conversion of da Vinci Xi robotic-assisted surgery to open surgery	Assessed during procedure
Safety: Adverse event rates	Incidence of intraoperative and post-operative procedure and device-related adverse events compared to open NSM	Up to 42 days post-operatively
Safety: positive surgical margin rates	Incidence of positive surgical margins compared to open NSM	Up to 42 days post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oncological Outcomes (for cancer recurrence)	Recurrence	Up to 5 years
Oncological Outcomes (for disease-free survival)	Disease-free survival	Up to 5 years
Oncological Outcomes (for overall survival)	Overall survival	Up to 5 years
Patient-Report Outcomes (BREAST-Q)	BREAST-Q	Up to 5 years
Patient-Report Outcomes (NAC Questionnaire)	NAC Questionnaire	Up to 5 years
Patient-Report Outcomes (EQ-5D)	EQ-5D	Up to 1 year

Collaborators and Investigators

• Sponsor: Intuitive Surgical
• Investigators: Study Director: Madhu Gorrepati, Intuitive

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2031

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: January 30, 2023
• First Posted (Actual): February 9, 2023

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: breast cancer; breast; robotic; robot; mastectomy; Nipple sparing mastectomy; da Vinci; NSM; USA; Single-port; SP System
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Breast Diseases
• Other Study ID Numbers: ISI dV SP - NSM-01

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