Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy
Safety and Feasibility of Robotic Single-port (SP) Nipple Sparing Mastectomy: A Single Institution, Single Arm Pilot Trial
Deborah Farr, MD
90 participants
Mar 8, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- 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 Criteria9
- 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)
Interventions
This is a software-controlled, electro- mechanical system designed for surgeons to perform single port minimally invasive surgery.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05245812