Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing Mastectomy

Launched by INTUITIVE SURGICAL · Mar 26, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a robotic-assisted surgical system, called the da Vinci Surgical System, for performing a type of surgery known as prophylactic nipple-sparing mastectomy (NSM). This procedure is designed for women who are at increased risk of developing breast cancer and want to have their breast tissue removed while preserving the nipple. The trial is currently recruiting female participants aged 18 to 80 who have a body mass index (BMI) of 29 or less. Eligible participants should either be considering this surgery to reduce their cancer risk or already have breast cancer in one breast and want to prevent it in the other.

If you join the trial, you can expect to undergo this advanced robotic surgery, which aims to be less invasive than traditional methods. It's important to note that there are specific criteria to qualify, such as not having any current or recent breast cancer in the breast being treated, and certain health conditions that could affect your eligibility. Overall, this study is focused on improving surgical options for women at risk of breast cancer, and it aims to provide valuable insights into how well this robotic-assisted approach works in a preventive setting.

Gender

FEMALE

Eligibility criteria

• 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.