Clinical Research Directory
Browse clinical research sites, groups, and studies.
Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy
Sponsor: Deborah Farr, MD
Summary
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.
Official title: Safety and Feasibility of Robotic Single-port (SP) Nipple Sparing Mastectomy: A Single Institution, Single Arm Pilot Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2022-03-08
Completion Date
2027-02
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
da Vinci SP Surgical System
This is a software-controlled, electro- mechanical system designed for surgeons to perform single port minimally invasive surgery.
Locations (1)
UT Southwestern
Dallas, Texas, United States