da Vinci SP Surgical System vs. Open Surgery in Nipple-Sparing Mastectomy

Purpose of this Study

We are doing this study to learn more about the use of the da Vinci Single-Port Surgical System in nipple-sparing mastectomy (NSM) procedures. We want to find out if the outcomes of NSM using this robotic-assisted technology are better than the current standard of open surgery.

Who Can Participate?

Eligibility

Women ages 21+ who:
  • Are diagnosed with early stage breast cancer
  • Have a BMI less than 30
  • Have a breast cup size C or smaller
  • Do not use tobacco
For more information about this study, please contact the study team at kimberly.turnage@duke.edu.

Age Range

21-110

Sex/Genders

Female (cisgender)
Looking for Healthy Participants
No

What is Involved?

Description

If you choose to join this study, you will get a random assignment (like a coin flip) to 1 of 2 groups:
  • One group of participants will have their NSMs performed using the da Vinci system
  • The other group of participants will have their NSMs performed by standard open surgery
The open surgery NSM procedure in this study is the same procedure you would have if you choose not to participate in this study. The robotic-assisted NSM procedure uses an investigational device, and it can only be done under a clinical study at this time.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

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

Study Website

Study Website

Principal Investigator

Akiko
Chiba

Protocol Number

PRO00112814

NCT ID

NCT05720039

Phase

N/A

Enrollment Status

Open to Enrollment
ClinicalTrials.gov