Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Part of paid clinical trials in Dallas, Texas.

Sponsor
Deborah Farr, MD
Study ID
NCT05245812
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Mar 8, 2022
Status verified
Jul 2025
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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)

Primary Outcome Measure

Number of participants who complete single port nipple sparing mastectomy (SPrNSM) [ Time Frame: Date of surgery (Day 1) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT SouthwesternDallasTexas75390
Deborah E Farr, MD

Find similar trials in Dallas, TX

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
UT Southwestern· Dallas, TX

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