A Study to Evaluate the da Vinci® Xi™ Surgical System in Nipple Sparing Mastectomy (NSM) Procedures

Overview

About this study

The purpose of this study is to evaluate the safety and effectiveness of the da Vinci Xi Surgical System in Nipple Sparing Mastectomy procedures.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Subject is female.
  • Subject has a BMI ≤ 29.
  • Subject is between 18 and 80 years of age.
  • Subject is a candidate for a unilateral or bilateral nipple sparing mastectomy procedure with mmediate reconstruction.
  • Subject is at increased risk for breast cancer and is seeking prophylactic NSM surgery.
  • Subject has no presence of occult cancer as confirmed by physical exam and by preoperative imaging per institution’s guidelines.  Known carriers of pathogenic BRCA1/2 mutations should have negative breast MRI.
  • Subject has breast ptosis ≤ Grade 2.
  • Subject has cup size ≤ C.
  • Subject is at low to moderate risk for anesthesia (ASA class I, II or III).
  • Subject is willing and able to provide written informed consent.
  • Subject is willing and able to comply with the study protocol requirements including follow up examinations up to 5 years (+/- 90 days) post operatively.

Exclusion Criteria:

  • Subject has current or prior history of ipsilateral in-situ or invasive breast carcinoma.
  • Subject has had previous breast surgery of the ipsilateral breast (excluding needle or core biopsies).
  • Subject has an inflammatory and/or infectious skin condition and/or unhealed wounds on the ipsilateral breast.
  • Subject has had chemotherapy for contralateral breast cancer within 3 weeks.
  • Subject has had previous radiation treatment to the ipsilateral breast/chest area.
  • Subject is planned to have other concomitant procedures (oophorectomy, hysterectomy, etc.).
  • Subject has a current history of smoking or has smoked within 1 month of screening.
  • Subject has hemoglobin A1C levels ≥ 8.
  • Subject has a high risk for anesthesia (ASA class ≥ IV) or significant medical comorbidities (i.e., cardiac, pulmonary and neurologic) that preclude longer anesthesia times.
  • Subject is contraindicated for general anesthesia or surgery.
  • Subject has a known bleeding or clotting disorder.
  • Subject is pregnant or suspected to be pregnant or is lactating.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

James Jakub, M.D.

Open for enrollment

Contact information:

Jennifer Krogman

(507) 538-3320

Krogman.Jennifer@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

James Jakub, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20520126

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