A Prospective, Multicenter Randomized Controlled Trial(RCT) of the da Vinci® SP™ Surgical System vs Open Surgery in Nipple Sparing Mastectomy (NSM) Procedures
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 21
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
City of Hope
RECRUITING
Irvine
Cedars-Sinai
RECRUITING
Los Angeles
Florida
Mayo Clinic Florida
RECRUITING
Jacksonville
Georgia
Emory University
RECRUITING
Atlanta
Illinois
Endeavor Health
RECRUITING
Evanston
Michigan
Corewell
RECRUITING
Detroit
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
Missouri
Washington University, St. Louis
RECRUITING
St Louis
North Carolina
Duke University
RECRUITING
Durham
New York
Northwell Health
RECRUITING
Lake Success
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Tennessee
Vanderbilt
NOT_YET_RECRUITING
Nashville
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Washington
University of Washington
RECRUITING
Seattle
Wisconsin
Ascension St. Columbia Mary's
RECRUITING
Milwaukee
Contact Information
Primary
Brittanny Boyer
brittanny.boyer@intusurg.com
610-413-3171
Time Frame
Start Date: 2023-05-08
Estimated Completion Date: 2030-12
Participants
Target number of participants: 204
Treatments
Experimental: Robotic NSM with da Vinci SP
Subjects randomized to this arm will undergo robotic NSM (RNSM) procedures
Active_comparator: Open NSM
Subjects randomized to this arm will undergo conventional open NSM procedures
Related Therapeutic Areas
Sponsors
Leads: Intuitive Surgical