Robotic vs. Open NSM for Early Stage Breast Cancer

Last updated: February 20, 2026
Sponsor: Intuitive Surgical
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cancer

Breast Cancer

Treatment

Open NSM

Robotic NSM

Clinical Study ID

NCT05720039
ISI dV SP - NSM-01
  • Ages > 21
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 204
Treatment Group(s): 2
Primary Treatment: Open NSM
Phase:
Study Start date:
May 08, 2023
Estimated Completion Date:
March 31, 2031

Study 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.

Connect with a study center

  • City of Hope

    Duarte, California 91010
    United States

    Site Not Available

  • City of Hope

    Irvine, California 92618
    United States

    Site Not Available

  • Cedars-Sinai

    Los Angeles, California 940048
    United States

    Site Not Available

  • City of Hope

    Irvine 5359777, California 5332921 92618
    United States

    Site Not Available

  • Cedars-Sinai

    Los Angeles 5368361, California 5332921 940048
    United States

    Site Not Available

  • Mayo Clinic Florida

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Mayo Clinic Florida

    Jacksonville 4160021, Florida 4155751 32224
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Emory University

    Atlanta 4180439, Georgia 4197000 30342
    United States

    Site Not Available

  • Endeavor Health

    Evanston, Illinois 60201
    United States

    Site Not Available

  • NorthShore University HealthSystem

    Evanston, Illinois 60201
    United States

    Site Not Available

  • Endeavor Health

    Evanston 4891382, Illinois 4896861 60201
    United States

    Site Not Available

  • Corewell

    Detroit, Michigan 48073
    United States

    Site Not Available

  • Corewell

    Detroit 4990729, Michigan 5001836 48073
    United States

    Site Not Available

  • Mayo Clinic Rochester

    Rochester, Minnesota 55902
    United States

    Site Not Available

  • Mayo Clinic Rochester

    Rochester 5043473, Minnesota 5037779 55902
    United States

    Site Not Available

  • Washington University, St. Louis

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University, St. Louis

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University, St. Louis

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Northwell Health

    Lake Success, New York 11042
    United States

    Site Not Available

  • Northwell Health

    Lake Success 5123853, New York 5128638 11042
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Duke University

    Durham 4464368, North Carolina 4482348 27710
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Site Not Available

  • Vanderbilt

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Vanderbilt

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98195
    United States

    Site Not Available

  • University of Washington

    Seattle 5809844, Washington 5815135 98195
    United States

    Site Not Available

  • Ascension St. Columbia Mary's

    Milwaukee, Wisconsin 53211
    United States

    Site Not Available

  • Ascension St. Columbia Mary's

    Milwaukee 5263045, Wisconsin 5279468 53211
    United States

    Site Not Available

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