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Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing Mastectomy
Trial Status: active
This study evaluates the safety and effectiveness of the da Vinci Surgical Systems in
prophylactic Nipple Sparing Mastectomy procedures.
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.
Additional locations may be listed on ClinicalTrials.gov for NCT03892980.
Locations matching your search criteria
United States
Florida
Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not Available
Minnesota
Rochester
Mayo Clinic in Rochester
Status: Active
Name Not Available
Pennsylvania
Philadelphia
University of Pennsylvania/Abramson Cancer Center
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
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 Surgical Systems in