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Clinical Trials in the USA / NCT05720039
Active, not recruiting Not applicable

Robotic vs. Open NSM for Early Stage Breast Cancer

NCT05720039 · tracked via the Priya Life Science USA tracker
Sponsor
Intuitive Surgical
Phase
Not applicable
Started
2023-05-08
Last updated
2026-02-24

Condition(s) studied

Breast Cancer FemaleBreast CancerBreast Cancer, Early-OnsetBreast DiseaseBreast

Investigational drug(s) / intervention(s)

Robotic NSMOpen NSM

Robotic NSM: Robotic-assisted Nipple sparing mastectomy procedures

Open NSM: open nipple-sparing mastectomy procedures

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

Sex
FEMALE
Min age
21 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (15)

FacilityCityRegionStatus
City of Hope Irvine California
Cedars-Sinai Los Angeles California
Mayo Clinic Florida Jacksonville Florida
Emory University Atlanta Georgia
Endeavor Health Evanston Illinois
Corewell Detroit Michigan
Mayo Clinic Rochester Rochester Minnesota
Washington University, St. Louis St Louis Missouri
Northwell Health Lake Success New York
Duke University Durham North Carolina
University of Pennsylvania Philadelphia Pennsylvania
Vanderbilt Nashville Tennessee
MD Anderson Cancer Center Houston Texas
University of Washington Seattle Washington
Ascension St. Columbia Mary's Milwaukee Wisconsin

More Intuitive Surgical trials in the USA

SP Thoracic IDE Study Active, not recruiting
Clinical Investigation of the da Vinci Surgical System Active, not recruiting
da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures Active, not recruiting
IS-001 Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery Recruiting
Open Nipple Sparing Mastectomy (NSM) Active, not recruiting

Other trials for the same condition

Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study Enrolling by invitation
Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer Active, not recruiting
Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009) Recruiting
Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) Active, not recruiting
Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05720039 on ClinicalTrials.gov ↗ ← All trials in the USA