Da Vinci Xi NSM IDE Study
- 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.
- 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.
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
Trial Phase Phase NA
Trial Type Prevention
- Primary ID ISI dV Xi-NSM
- Secondary IDs NCI-2020-13868
- Clinicaltrials.gov ID NCT03892980