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

March 7, 2024 updated by: Intuitive Surgical

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

Recruiting

Conditions

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Principal Investigator:
          • Jennifer Tseng, MD
        • Sub-Investigator:
          • Jamie Rand, MD
        • Contact:
        • Contact:
          • Stephanie Casal, MS, RN, CNS
          • Phone Number: 949-671-4112
          • Email: scasal@coh.org
        • Sub-Investigator:
          • Mouchammed Agko, MD
        • Sub-Investigator:
          • Antoine Carre, MD
        • Sub-Investigator:
          • Katharine Schulz-Costello, DO
      • Los Angeles, California, United States, 940048
        • Recruiting
        • Cedars-Sinai
        • Principal Investigator:
          • Farin Amersi, MD
        • Sub-Investigator:
          • Alice Chung, MD
        • Contact:
        • Sub-Investigator:
          • Kjirsten Carlson, MD
        • Sub-Investigator:
          • Marissa Boyle, MD
        • Sub-Investigator:
          • Edward Ray, MD
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Florida
        • Principal Investigator:
          • James Jakub, MD
        • Contact:
        • Sub-Investigator:
          • Sarah McLaughlin, MD
        • Sub-Investigator:
          • Brian Rinker, MD
        • Sub-Investigator:
          • Olivia Ho, MD
        • Sub-Investigator:
          • Tammeza Gibson, PA
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Emory University
        • Principal Investigator:
          • Cathy Graham, MD
        • Contact:
        • Sub-Investigator:
          • Clara Farley, MD
        • Sub-Investigator:
          • Sarah Apatov, PA
        • Sub-Investigator:
          • Peter Thompson, MD
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • NorthShore University Healthsystem
        • Principal Investigator:
          • Katherine Kopkash, MD
        • Contact:
        • Contact:
    • Michigan
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Recruiting
        • Mayo Clinic Rochester
        • Principal Investigator:
          • Mara Piltin, DO
        • Contact:
          • Mara Piltin, DO
          • Phone Number: 507-284-3975
        • Contact:
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University, St. Louis
        • Principal Investigator:
          • Rebecca Aft, MD
        • Contact:
        • Sub-Investigator:
          • Joani Christensen, MD
    • New York
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Northwell Health
        • Principal Investigator:
          • Alan Kadison, MD
        • Contact:
        • Sub-Investigator:
          • Gary Deutsche, MD
        • Sub-Investigator:
          • Neil Tanna, MD
        • Sub-Investigator:
          • Armen Kasabian, MD
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University
        • Principal Investigator:
          • Akiko Chiba, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Shelley Hwang, MD
        • Sub-Investigator:
          • Laura Rosenberger, MD
        • Sub-Investigator:
          • Geoffrey Sisk, MD
        • Sub-Investigator:
          • Rebecca Knackstedt, MD
        • Sub-Investigator:
          • Maggie Dinome, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Not yet recruiting
        • Vanderbilt
        • Contact:
          • Kathy Taylor
        • Contact:
          • Kelly Hewitt, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Principal Investigator:
          • Rosa Hwang, MD
        • Contact:
        • Sub-Investigator:
          • Joani Christensen, MD
        • Sub-Investigator:
          • Solange Cox, MD
        • Sub-Investigator:
          • Renee Largo, MD
        • Sub-Investigator:
          • John Shuck, MD
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sara Javid, MD
        • Sub-Investigator:
          • Meghan Flanagan, MD
        • Sub-Investigator:
          • Suzanne Marie Inchauste, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53211
        • Recruiting
        • Ascension St. Columbia Mary's
        • Contact:
        • Principal Investigator:
          • Alysandra Lal, MD
        • Sub-Investigator:
          • John Yousif, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Assessed during procedure
Conversion is defined as conversion of da Vinci Xi robotic-assisted surgery to open surgery
Assessed during procedure
Safety: Adverse event rates
Time Frame: Up to 42 days post-operatively
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
Time Frame: Up to 42 days post-operatively
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)
Time Frame: Up to 5 years
Recurrence
Up to 5 years
Oncological Outcomes (for disease-free survival)
Time Frame: Up to 5 years
Disease-free survival
Up to 5 years
Oncological Outcomes (for overall survival)
Time Frame: Up to 5 years
Overall survival
Up to 5 years
Patient-Report Outcomes (BREAST-Q)
Time Frame: Up to 5 years
BREAST-Q
Up to 5 years
Patient-Report Outcomes (NAC Questionnaire)
Time Frame: Up to 5 years
NAC Questionnaire
Up to 5 years
Patient-Report Outcomes (EQ-5D)
Time Frame: Up to 1 year
EQ-5D
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intuitive Surgical

Investigators

  • Study Director: Kathryn Wine, Intuitive Surgical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

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)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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