Robotic vs. Open NSM for Early Stage Breast Cancer

Last updated: April 22, 2025
Sponsor: Intuitive Surgical
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

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:
December 31, 2030

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

    Active - Recruiting

  • Cedars-Sinai

    Los Angeles, California 940048
    United States

    Active - Recruiting

  • Mayo Clinic Florida

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Emory University

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

  • Endeavor Health

    Evanston, Illinois 60201
    United States

    Active - Recruiting

  • NorthShore University HealthSystem

    Evanston, Illinois 60201
    United States

    Site Not Available

  • Corewell

    Detroit, Michigan 48073
    United States

    Active - Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota 55902
    United States

    Active - Recruiting

  • Washington University, St. Louis

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University, St. Louis

    St. Louis, Missouri 63110
    United States

    Active - Recruiting

  • Northwell Health

    Lake Success, New York 11042
    United States

    Active - Recruiting

  • Duke University

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Vanderbilt

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Washington

    Seattle, Washington 98195
    United States

    Active - Recruiting

  • Ascension St. Columbia Mary's

    Milwaukee, Wisconsin 53211
    United States

    Active - Recruiting

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