Recruiting

Robotic SP Mastectomy

Sponsor:

Deborah Farr, MD

Code:

NCT05245812

Conditions

Breast Cancer

High Risk of Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

da Vinci SP Surgical System

Study Details

Brief 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.

Conditions

Breast Cancer

High Risk of Breast Cancer

Study ID

NCT05245812

Start date

Mar 8, 2022

Status verified date

Jul, 2025

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment arm (SPrNSM)

Patients will undergo Single Port robotic Nipple Sparing Mastectomy (SPrNSM) with immediate breast reconstruction with tissue expanders/implants and acellular dermal matrix (Alloderm)

Interventions

da Vinci SP Surgical System

This is a software-controlled, electro- mechanical system designed for surgeons to perform single port minimally invasive surgery.

Primary outcome measure

  • Number of participants who complete single port nipple sparing mastectomy (SPrNSM) [ Time Frame: Date of surgery (Day 1) ]
  • Incidence of perioperative complications [ Time Frame: 30 days following surgery ]

Central Contacts and Locations

Central contacts

Deborah Farr, MD, FACS

214-648-4133Deborah.Farr@UTSouthwestern.edu

Locations

UT Southwestern

Recruiting

Dallas, Texas, United States, 75390

More Information

Sponsor

Deborah Farr, MD

Last update posted

Mar 20, 2026

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Deborah Farr, MD on 2026-03-20.