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.
<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.
<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
Study Website
Principal Investigator
Akiko
Chiba
Protocol Number
PRO00112814
NCT ID
NCT05720039
Phase
N/A
Enrollment Status
Open to Enrollment