Robotic vs. Open NSM for Early Stage Breast Cancer

Running, not enrolling · Not applicable

Conditions studied: Breast Cancer Female, Breast Cancer, Breast Cancer, Early-Onset, Breast Disease, Breast

In brief

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

Key facts

Study ID

NCT05720039

Run by

Intuitive Surgical

People needed

204

Starts

2023-05-08

Expected to finish

2031-03-01

Last updated by the study team

2026-02-24

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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