RECRUITING

Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing Mastectomy

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Conditions

Nipple Sparing MastectomybreastrobotroboticNSMda Vincisurgerymastectomyprophylactic NSMrisk reducingBRCA mutationnipple areola complexNACRNSMhigh-risk genetic mutationgene mutation

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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 Surgical Systems in prophylactic Nipple Sparing Mastectomy procedures.

Official Title

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

Quick Facts

Study Start:2021-03-26
Study Completion:2029-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03892980

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:18 Years to 80 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female between ages 18-80.
  2. * BMI ≤ 29.
  3. * Candidate for an NSM procedure.
  4. * 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.
  5. * Breast ptosis ≤ Grade 2.
  6. * Cup size ≤ C.
  7. * 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.
  1. * Current or prior history of ipsilateral in-situ or invasive breast carcinoma on the breast for which she is seeking prophylactic NSM surgery.
  2. * Previous breast surgery of the ipsilateral breast (excluding needle or core biopsies and excisional biopsies performed more than 1 year prior).
  3. * Current history of smoking or has smoked within 1 year of screening.
  4. * Skin conditions
  5. * Uncontrolled diabetes mellitus.
  6. * Previous chemotherapy or radiation
  7. * High risk for anesthesia or significant medical comorbidities
  8. * Contraindicated for general anesthesia or surgery.
  9. * Known bleeding or clotting disorder.
  10. * Pregnant or suspected to be pregnant or is lactating.

Contacts and Locations

Study Contact

Tish Mikoczi
CONTACT
760-274-5811
NSM-Xi@intusurg.com

Study Locations (Sites)

Mayo Clinic Florida
Jacksonville, Florida, 32224
United States
NorthShore University Health System
Evanston, Illinois, 60201
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Northwell Health
New Hyde Park, New York, 11040
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Intuitive Surgical

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 Date2021-03-26
Study Completion Date2029-12-30

Study Record Updates

Study Start Date2021-03-26
Study Completion Date2029-12-30

Terms related to this study

Keywords Provided by Researchers

  • breast
  • robot
  • robotic
  • nipple sparing mastectomy
  • NSM
  • da Vinci
  • surgery
  • mastectomy
  • prophylactic NSM
  • risk reducing
  • BRCA mutation
  • nipple areola complex
  • NAC
  • RNSM
  • high-risk genetic mutation
  • gene mutation

Additional Relevant MeSH Terms

  • Nipple Sparing Mastectomy