Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy
Safety and Feasibility of Robotic Single-port (SP) Nipple Sparing Mastectomy: A Single Institution, Single Arm Pilot Trial
Deborah Farr, MD
90 participants
Mar 8, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
This is a software-controlled, electro- mechanical system designed for surgeons to perform single port minimally invasive surgery.
Locations(1)
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NCT05245812