Robotic Vs. Open NSM for Early Stage Breast Cancer

Description

This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.

Conditions

Breast Cancer Female, Breast Cancer, Breast Cancer, Early-Onset, Breast Disease, Breast

Study Overview

Study Details

Study overview

This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.

A Prospective, Multicenter Randomized Controlled Trial(RCT) of the Da Vinci® SP™ Surgical System Vs Open Surgery in Nipple Sparing Mastectomy (NSM) Procedures

Robotic Vs. Open NSM for Early Stage Breast Cancer

Condition
Breast Cancer Female
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope, Duarte, California, United States, 91010

Los Angeles

Cedars-Sinai, Los Angeles, California, United States, 940048

Jacksonville

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

Atlanta

Emory University, Atlanta, Georgia, United States, 30342

Evanston

Endeavor Health, Evanston, Illinois, United States, 60201

Detroit

Corewell, Detroit, Michigan, United States, 48073

Rochester

Mayo Clinic Rochester, Rochester, Minnesota, United States, 55902

St. Louis

Washington University, St. Louis, St. Louis, Missouri, United States, 63110

Lake Success

Northwell Health, Lake Success, New York, United States, 11042

Durham

Duke University, Durham, North Carolina, United States, 27710

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 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.
  • * 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

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Intuitive Surgical,

Madhu Gorrepati, STUDY_DIRECTOR, Intuitive

Study Record Dates

2030-12