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:<ul>
<li>Are diagnosed with early stage breast cancer</li>
<li>Have a BMI less than 30</li>
<li>Have a breast cup size C or smaller</li>
<li>Do not use tobacco</li></ul>
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?

If you choose to join this study, you will get a random assignment (like a coin flip) to 1 of 2 groups:<ul>
<li>One group of participants will have their NSMs performed using the da Vinci system</li>
<li>The other group of participants will have their NSMs performed by standard open surgery</li></ul>
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

Principal Investigator

Akiko
Chiba

Protocol Number

PRO00112814

NCT ID

NCT05720039

Phase

N/A

Enrollment Status

Open to Enrollment