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.
- 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?
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.
- 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
Principal Investigator
Akiko
Chiba
Protocol Number
PRO00112814
NCT ID
NCT05720039
Enrollment Status
OPEN TO ACCRUAL