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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
Who can join
Ages 18 to 80 · Women
Full eligibility criteria
Inclusion Criteria: * Candidates for open nipple sparing mastectomy, per standard of care with regards to anatomic factors and tumor location including: nipple sparing resection and resection OR prophylactic mastectomy for risk reduction 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 Exclusion Criteria: * Inability to provide informed consent * Pregnant or nursing women * Patients with: * 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 (defined as \> 20 cigarettes per day)
About the study
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.
What is being tested
- da Vinci SP Surgical System (device)
Sponsor: Deborah Farr, MD · Participants: 90 · Started: Mar 8, 2022
Contact the study team
- Deborah Farr, MD, FACS · Phone: 214-648-4133
Official record on ClinicalTrials.gov — NCT05245812
Locations in the U.S.
| Texas | UT Southwestern, Dallas |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.