Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Description

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

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Study Overview

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Study Details

Study overview

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.

Safety and Feasibility of Robotic Single-port (SP) Nipple Sparing Mastectomy: A Single Institution, Single Arm Pilot Trial

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Dallas

UT Southwestern, Dallas, Texas, United States, 75390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Deborah Farr, MD,

Deborah Farr, MD, FACS, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

2026-02