RecruitingNot ApplicableNCT05245812

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


Sponsor

Deborah Farr, MD

Enrollment

90 participants

Start Date

Mar 8, 2022

Study Type

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

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a nipple-sparing mastectomy (breast removal while preserving the nipple) can be done safely using a robotic surgical system. This approach may result in less visible scarring and better cosmetic outcomes compared to traditional open surgery. **You may be eligible if...** - You are a candidate for a nipple-sparing mastectomy based on your tumor's size and location - You are having a preventive mastectomy (for risk reduction) or being treated for early-stage breast cancer or DCIS (non-invasive breast cancer) - You are in good enough physical condition to tolerate surgery and anesthesia **You may NOT be eligible if...** - You have inflammatory breast cancer - The skin over your breast or the nipple area is involved with tumor - You have significant drooping of the nipple (Grade 3 or higher ptosis) - You are pregnant or nursing - You are a heavy smoker (more than 20 cigarettes per day) - You cannot safely receive general anesthesia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEda 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

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NCT05245812


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