Robotic-Assisted Da Vinci System Prophylactic Nipple-Sparing Mastectomy

Overview

About this study

This study evaluates the safety and effectiveness of the da Vinci Surgical Systems in prophylactic 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:

* 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.

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
Jacksonville, Fla. Mayo Clinic principal investigator James Jakub, M.D.	Contact us for the latest status	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015
Rochester, Minn. Mayo Clinic principal investigator Mara Piltin, D.O.	Closed for enrollment	Contact information: Jennie Musty 5075384849 cancerclinicaltrialsreferrals@mayo.edu

Mayo Clinic Location

Status

Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

James Jakub, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Mara Piltin, D.O.

Closed for enrollment

Contact information:

Jennie Musty

5075384849

cancerclinicaltrialsreferrals@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials