Robotic vs. Open NSM for Early Stage Breast Cancer

Overview

About this study

The purpose of this study is to evaluate the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM 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:

Female age 21 or older.
BMI < 30.
Candidate for an NSM procedure with immediate reconstruction.
Diagnosis of early stage brest cancer.
Breast ptosis ≤ Grade 2.
Cup size ≤ C.

Exclusion Criteria:

Previous breast surgery.
Diagnosis of metastatic breast cancer.
Prior radiation treatment to the chest.
Current smokers.
Contraindication for general anesthesia or surgery.
Known bleeding or clotting disorder.
Pregnant or suspected to be pregnant, or actively breastfeeding.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 5/9/23. Questions regarding updates should be directed to the study team contact.

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 Mara Piltin, D.O.	Open for enrollment	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015
Jacksonville, Fla. Mayo Clinic principal investigator James Jakub, M.D.	Open for enrollment	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mara Piltin, D.O.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

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

Clinical Trials