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Evaluation of Sensibility with Targeted Nipple Areola Complex Re-innervation in Nipple Sparing Mastectomy
Scottsdale/Phoenix, AZ
To determine the effectiveness of targeted nipple areola complex (NAC) re-innervation for improving sensibility in women undergoing nipple sparing mastectomy (NSM).
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MC230302
Jacksonville, FL
This is a prospective, phase II trial to assess feasibility of patients undergoing NSM willingness to be randomized to neurotization or not. Feasibility is to be established in preparation for a larger, multi-site randomized prospective trial aimed at determining if neurotization improves objective and subjective patient outcomes. Patients undergoing NSM through an inframammary incision with prosthetic-based reconstruction will be randomized to undergo neurotization of the NAC (intervention) or not (control).
Feasibility will be defined as the accrual of 7 patients within a year (or 14 patients within 2 years).
Hypothesis: Patients undergoing NSM will be willing ...
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A Study to Evaluate the da Vinci® Xi™ Surgical System in Nipple Sparing Mastectomy (NSM) Procedures
Rochester, MN; Jacksonville, FL
The purpose of this study is to evaluate the safety and effectiveness of the da Vinci Surgical Systems in Nipple Sparing Mastectomy procedures.
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Open Nipple Sparing Mastectomy (NSM)
Rochester, MN
The purpose of this retrospective study is to evaluate the complication rate of prophylactic open NSM procedures through 42 days follow-up from retrospective chart review at the same investigators and institutions as those included under IDE Study protocol G190065/A001.
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A Study to Evaluate Same Day Discharge Post-mastectomy with/without Alloplastic Breast Reconstruction
Rochester, MN
In the light of the pandemic, institutions have had to take greater precautions and instigate procedures to aim to improve safety and reduce risk for patients undergoing surgery. One intiative was designed to implement a same day discharge for patients undergoing mastectomy with or without alloplastic reconstruction. This study aims to evaluate the outcomes and patient satisfaction with same day mastectomy with or without alloplastic reconstruction following COVID-19 and compare satisfaction and outcomes (e.g complications) with patients pre-COVID 19. This is part of a quality improvement project.