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Da Vinci Xi NSM IDE Study

Trial Status: Active

This study evaluates the safety and effectiveness of the da Vinci Xi Surgical System in 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.
  • 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.


M D Anderson Cancer Center
Status: ACTIVE

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.

Trial Phase Phase NA

Trial Type Prevention

Lead Organization
Intuitive Surgical

  • Primary ID ISI dV Xi-NSM
  • Secondary IDs NCI-2020-13868
  • ID NCT03892980