Robotic-Assisted da Vinci Xi Prophylactic Nipple-Sparing Mastectomy

Study Overview
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Brief Summary
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This study evaluates the safety and effectiveness of the da Vinci Xi Surgical System in prophylactic Nipple Sparing Mastectomy procedures.

Detailed Description
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Surgical management for breast cancer and risk-reducing techniques have evolved from radical mastectomy to other techniques such as nipple and skin sparing procedures. Nipple-sparing mastectomy (NSM) with reconstruction technology offers the opportunity to preserve the shape of both the breast and the nipple-areola complex. This study will evaluate the safety and effectiveness of the da Vinci Xi Surgical System in NSM procedures.

Official Title
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A Prospective, Multicenter Investigation of the da Vinci® Xi™ Surgical System in Nipple Sparing Mastectomy (NSM) Procedures

Conditions
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Nipple Sparing Mastectomy

Intervention / Treatment
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* Device: Nipple-Sparing Mastectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female between ages 18-80. BMI ≤ 29. Candidate for an NSM procedure. At increased risk for breast cancer and is seeking prophylactic NSM surgery or subject has breast cancer in one breast and is seeking prophylactic NSM on contralateral side. Breast ptosis ≤ Grade 2. Cup size ≤ C. No presence of occult cancer on the side for which she is seeking prophylactic NSM surgery as confirmed by physical exam and by preoperative imaging per institution's guidelines. Exclusion Criteria: Current or prior history of ipsilateral in-situ or invasive breast carcinoma on the breast for which she is seeking prophylactic NSM surgery. Previous breast surgery of the ipsilateral breast (excluding needle or core biopsies and excisional biopsies performed more than 1 year prior). Current history of smoking or has smoked within 1 year of screening. Skin conditions Uncontrolled diabetes mellitus. Previous chemotherapy or radiation High risk for anesthesia or significant medical comorbidities Contraindicated for general anesthesia or surgery. Known bleeding or clotting disorder. Pregnant or suspected to be pregnant or is lactating.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Subjects undergo nipple-sparing mastectomy (NSM) procedures using the da Vinci Xi Surgical System
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nipple Sparing Mastectomy<br> | Device: Nipple-Sparing Mastectomy<br>* Nipple-sparing mastectomy using da Vinci Xi Surgical System.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness: No conversions to open NSM | Conversion is defined as conversion of da Vinci Xi robotic-assisted surgery to open surgery | Assessed during surgery | 
| Primary Safety: Incidence of adverse events | Incidence of intraoperative and post-operative procedure and device-related adverse events | Assessed during surgery to 42 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prophylactic NSM, breast, robot, robotic, nipple sparing mastectomy, NSM, da Vinci, surgery, mastectomy