NCT05720039

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
58mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

15 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
May 2023Mar 2031

First Submitted

Initial submission to the registry

January 17, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

May 8, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2031

Expected
Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

2.8 years

First QC Date

January 17, 2023

Last Update Submit

February 20, 2026

Conditions

Breast Cancer FemaleBreast CancerBreast DiseaseBreast Cancer, Early-OnsetBreast

Keywords

roboticNSMNipple sparing mastectomyda Vincibreast cancermastectomybreastUSArobotSP SystemSingle-port

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • Oncological Outcomes (for cancer recurrence)

    Up to 5 years

  • Oncological Outcomes (for disease-free survival)

    Up to 5 years

  • Oncological Outcomes (for overall survival)

    Up to 5 years

  • Patient-Report Outcomes (BREAST-Q)

    Up to 5 years

  • Patient-Report Outcomes (NAC Questionnaire)

    Up to 5 years

  • +1 more secondary outcomes

Study Arms (2)

Robotic NSM with da Vinci SP

EXPERIMENTAL

Subjects randomized to this arm will undergo robotic NSM (RNSM) procedures

Device: Robotic NSM

Open NSM

ACTIVE COMPARATOR

Subjects randomized to this arm will undergo conventional open NSM procedures

Procedure: Open NSM

Interventions

Robotic NSMDEVICE

Robotic-assisted Nipple sparing mastectomy procedures

Also known as: RNSM, SP NSM
Robotic NSM with da Vinci SP
Open NSMPROCEDURE

open nipple-sparing mastectomy procedures

Open NSM

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

City of Hope

Irvine, California, 92618, United States

Location

Cedars-Sinai

Los Angeles, California, 940048, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Emory University

Atlanta, Georgia, 30342, United States

Location

Endeavor Health

Evanston, Illinois, 60201, United States

Location

Corewell

Detroit, Michigan, 48073, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55902, United States

Location

Washington University, St. Louis

St Louis, Missouri, 63110, United States

Location

Northwell Health

Lake Success, New York, 11042, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

Vanderbilt

Nashville, Tennessee, 37232, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Ascension St. Columbia Mary's

Milwaukee, Wisconsin, 53211, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsBreast Diseases

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Madhu Gorrepati

    Intuitive

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Subjects undergo nipple-sparing mastectomy (NSM) procedures using the da Vinci SP Surgical System or open NSM
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2023

First Posted

February 9, 2023

Study Start

May 8, 2023

Primary Completion

March 1, 2026

Study Completion (Estimated)

March 1, 2031

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(15)