Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

NCT05245812 | Recruiting DMC FDA Device

• 1 other identifier: STU-2022-0091
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Number of participants who complete single port nipple sparing mastectomy (SPrNSM)

  The number of participants who complete single port nipple sparing mastectomy (SPrNSM) will be measured.

  Date of surgery (Day 1)

• Incidence of perioperative complications

  Perioperative complications will be described using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACAE) v. 4.03 criteria. Complications will refer to any medical occurrence directly attributed to the surgical procedure during and within the first 30 days following use of the SP robotic platform and ADM. Grade 3, 4, or 5 complication or adverse event will constitute an event. Perioperative complication rates will be compared to historical complication rates.

  30 days following surgery

Secondary Outcomes (8)

• Number of participants with positive margins

  2 weeks following date of surgery

• Number of participants with new breast cancers

  following date of surgery up to 5 years

• Number of participants with recurrent breast cancers

  following date of surgery up to 5 years

• Patient satisfaction as measured by BREAST-Q reconstruction tool

  Baseline, postoperatively at 2 weeks, every 6 months for 5 years

• Patient satisfaction as measured by BREAST-Q sensation tool

  Baseline, postoperatively at 2 weeks, every 6 months for 5 years

Study Arms (1)

Treatment arm (SPrNSM)

EXPERIMENTAL

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

Device: da Vinci SP Surgical System

Interventions

da Vinci SP Surgical System DEVICE

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

Also known as: da Vinci SP Surgical System, Model SP1098

Treatment arm (SPrNSM)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Deborah Farr, MD: lead

Study Sites (1)

UT Southwestern

Dallas, Texas, 75390, United States

RECRUITING

Related Publications (1)

• Farr DE, Haddock NT, Tellez J, Radi I, Alterio R, Sayers B, Zeh H 3rd. Safety and Feasibility of Single-Port Robotic-Assisted Nipple-Sparing Mastectomy. JAMA Surg. 2024 Mar 1;159(3):269-276. doi: 10.1001/jamasurg.2023.6999.

  PMID: 38231502 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Deborah Farr, MD, FACS

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah Farr, MD, FACS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: ASSOC PROFESSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 18, 2022
• Study Start: March 8, 2022
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)