Actively Recruiting
Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy
Led by Deborah Farr, MD · Updated on 2026-03-20
90
Participants Needed
1
Research Sites
255 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Candidates for open nipple sparing mastectomy based on anatomic factors and tumor location, including nipple sparing resection, prophylactic mastectomy, or treatment of ductal carcinoma in-situ or clinically node negative cT1-T3 breast cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
You will not qualify if you...
- Unable to provide informed consent
- Pregnant or nursing women
- Inflammatory breast cancer
- Skin involvement with tumor
- Pre-operative diagnosis of Nipple Areolar Complex (NAC) tumor involvement
- Grade 3 or higher nipple ptosis
- Contraindicated for general anesthesia or surgery
- Heavy current smoking history (more than 20 cigarettes per day)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UT Southwestern
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
D
Deborah Farr, MD, FACS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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