da Vinci SP Surgical System vs. Open Surgery in Nipple-Sparing Mastectomy - Clinical Trial
What is the 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.
Mastectomy
Who Can Participate in the Study?
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.
What is Involved?
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.
Study Details
