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Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

RecruitingNAAges 18 Years - 80 YearsFemaleDeborah Farr, MD
NCT05245812 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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)
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What it tests

  • da Vinci SP Surgical System
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Where

1 site
UT Southwestern
Dallas, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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