ACTIVE_NOT_RECRUITING

Robotic vs. Open NSM for Early Stage Breast Cancer

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Conditions

Breast Cancer FemaleBreast CancerBreast Cancer, Early-OnsetBreast DiseaseBreastroboticNSMNipple sparing mastectomyda VincimastectomyUSArobotSP SystemSingle-port

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2023-05-08
Study Completion:2030-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05720039

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.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female age 21 or older
  2. * BMI \< 30
  3. * Candidate for an NSM procedure with immediate reconstruction
  4. * Diagnosis of early stage brest cancer
  5. * Breast ptosis ≤ Grade 2.
  6. * Cup size ≤ C.
  1. * Previous breast surgery
  2. * Diagnosis of metastatic breast cancer
  3. * Prior radiation treatment to the chest
  4. * Current smokers
  5. * Contraindication for general anesthesia or surgery.
  6. * Known bleeding or clotting disorder.
  7. * Pregnant or suspected to be pregnant, or actively breastfeeding

Contacts and Locations

Principal Investigator

Madhu Gorrepati
STUDY_DIRECTOR
Intuitive

Study Locations (Sites)

City of Hope
Irvine, California, 92618
United States
Cedars-Sinai
Los Angeles, California, 940048
United States
Mayo Clinic Florida
Jacksonville, Florida, 32224
United States
Emory University
Atlanta, Georgia, 30342
United States
Endeavor Health
Evanston, Illinois, 60201
United States
Corewell
Detroit, Michigan, 48073
United States
Mayo Clinic Rochester
Rochester, Minnesota, 55902
United States
Washington University, St. Louis
St Louis, Missouri, 63110
United States
Northwell Health
Lake Success, New York, 11042
United States
Duke University
Durham, North Carolina, 27710
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
United States
Vanderbilt
Nashville, Tennessee, 37232
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
University of Washington
Seattle, Washington, 98195
United States
Ascension St. Columbia Mary's
Milwaukee, Wisconsin, 53211
United States

Collaborators and Investigators

Sponsor: Intuitive Surgical

  • Madhu Gorrepati, STUDY_DIRECTOR, Intuitive

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-08
Study Completion Date2030-12

Study Record Updates

Study Start Date2023-05-08
Study Completion Date2030-12

Terms related to this study

Keywords Provided by Researchers

  • robotic
  • NSM
  • Nipple sparing mastectomy
  • da Vinci
  • breast cancer
  • mastectomy
  • breast
  • USA
  • robot
  • SP System
  • Single-port

Additional Relevant MeSH Terms

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