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ACTIVE NOT RECRUITING
NCT05720039
NA

Robotic vs. Open NSM for Early Stage Breast Cancer

Sponsor: Intuitive Surgical

View on ClinicalTrials.gov

Summary

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

Official title: A Prospective, Multicenter Randomized Controlled Trial(RCT) of the da Vinci® SP™ Surgical System vs Open Surgery in Nipple Sparing Mastectomy (NSM) Procedures

Key Details

Gender

FEMALE

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

204

Start Date

2023-05-08

Completion Date

2031-03

Last Updated

2026-02-24

Healthy Volunteers

No

Interventions

DEVICE

Robotic NSM

Robotic-assisted Nipple sparing mastectomy procedures

PROCEDURE

Open NSM

open nipple-sparing mastectomy procedures

Locations (15)

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