Breast Cancer Clinical Trial
Robotic-Assisted da Vinci Xi Prophylactic Nipple-Sparing Mastectomy
Summary
This study evaluates the safety and effectiveness of the da Vinci Xi Surgical System in prophylactic Nipple Sparing Mastectomy procedures.
Full Description
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.
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.
Breast ptosis ≤ Grade 2.
Cup size ≤ C.
No presence of occult cancer 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.
Previous breast surgery of the ipsilateral breast
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.
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There are 6 Locations for this study
Jacksonville Florida, 32224, United States More Info
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Principal Investigator
Evanston Illinois, 60201, United States More Info
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Principal Investigator
Rochester Minnesota, 55905, United States More Info
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New Hyde Park New York, 11040, United States More Info
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Philadelphia Pennsylvania, 19107, United States More Info
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Houston Texas, 77030, United States More Info
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