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Ensaio clínico

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

NCT: NCT05245812 · RECRUITING

ID NCTNCT05245812
EstadoRECRUITING
Data de início2022-03-08
SponsorDeborah Farr, MD (OTHER)
First posted
Last updated

Resumo breve

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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