Recruiting

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

ClinicalTrials.gov IDNCT05245812

PhaseNA

Enrollment90

SponsorDeborah Farr, MD

Age18 Years – 80 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Breast Cancer, High Risk of Breast Cancer

About this 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.

Interventions

Device: da Vinci SP Surgical System — This is a software-controlled, electro- mechanical system designed for surgeons to perform single port minimally invasive surgery.

Primary outcomes

Number of participants who complete single port nipple sparing mastectomy (SPrNSM) (Date of surgery (Day 1))
Incidence of perioperative complications (30 days following surgery)

Eligibility information

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)

Study locations

UT Southwestern, Dallas, Texas 75390 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-26.