Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Launched by DEBORAH FARR, MD · Feb 8, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new surgical approach called robotic nipple sparing mastectomy (rNSM) for women with breast cancer or those at high risk for it. The goal is to see if this robotic method, which uses advanced technology to remove breast tissue while preserving the nipple, is as safe and effective as traditional surgery. The study will also measure how satisfied patients are with their surgery, particularly regarding nipple sensation and overall outcomes.

To qualify for this trial, participants must be women who can undergo nipple sparing mastectomy based on their specific health needs and cancer type. They should have a good performance status, meaning they are generally healthy enough to handle the surgery. Those who are pregnant, nursing, or have certain types of breast cancer are not eligible. Participants can expect to have their safety and satisfaction tracked closely throughout the process, helping researchers learn more about this innovative surgical technique.

Gender

FEMALE

Eligibility criteria

• 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)