Looking for volunteers
Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy
NCT05245812 · Deborah Farr, MD · Updated 5 Oct 2026
- What is being tested
- da Vinci SP Surgical System
- For
- Breast Cancer; High Risk of Breast Cancer
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years to 80 years. About 90 people. The full rules are on the registry page.
- Where
- United States
- When
- Starts or started 8 March 2022, ends Feb 2027. Registered 18 Feb 2022.
- Results
- None posted yet.
In the researchers' words
This is a single arm, single-center, prospective clinical trial designed to track the peri, post-operative and oncologic outcomes when utilizing the da-Vinci single port (SP) robotic platform to perform robotic nipple sparing mastectomy (rNSM) and immediate breast reconstruction with tissue expanders/implants and acellular dermal matrix (ADM - Alloderm), for patients with breast cancer as well as those with a high risk for breast cancer. Safety and feasibility measures will be measured as primary outcome measures. Oncological and patient satisfaction outcome measures will be measured. Our hypothesis is that SPr-NSM is equal to open NSM in terms of safety, feasibility and oncological outcomes with improved patient satisfaction as measured by nipple sensation and patient reported outcomes.
Sites
- UT SouthwesternDallas, Texas, United States