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Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

NCT05245812 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-03-20

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Deborah Farr, MD

    lead OTHER

Principal Investigators

  • Deborah Farr, MD, FACS · University of Texas Southwestern Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-08
Primary Completion
2027-02-28
Completion
2027-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05245812 on ClinicalTrials.gov