Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing Mastectomy

Description

This study evaluates the safety and effectiveness of the da Vinci Surgical Systems in prophylactic Nipple Sparing Mastectomy procedures.

Conditions

Nipple Sparing Mastectomy

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Study Overview

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Study Details

Study overview

This study evaluates the safety and effectiveness of the da Vinci Surgical Systems in prophylactic Nipple Sparing Mastectomy procedures.

A Prospective, Multicenter Investigation of the da Vinci® Surgical Systems in Nipple Sparing Mastectomy (NSM) Procedures

Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing Mastectomy

Condition
Nipple Sparing Mastectomy
Intervention / Treatment

-

Contacts and Locations

Jacksonville

Mayo Clinic Florida, Jacksonville, Florida, United States, 32224

Evanston

NorthShore University Health System, Evanston, Illinois, United States, 60201

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

New Hyde Park

Northwell Health, New Hyde Park, New York, United States, 11040

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19107

Houston

MD Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Intuitive Surgical,

Study Record Dates

2029-12-30