RECRUITING

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

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 is a single arm, single-center, prospective clinical trial designed to track the peri, post-operative and oncologic outcomes when utilizing the da-Vinci single port (SP) robotic platform to perform robotic nipple sparing mastectomy (rNSM) and immediate breast reconstruction with tissue expanders/implants and acellular dermal matrix (ADM - Alloderm), for patients with breast cancer as well as those with a high risk for breast cancer. Safety and feasibility measures will be measured as primary outcome measures. Oncological and patient satisfaction outcome measures will be measured. Our hypothesis is that SPr-NSM is equal to open NSM in terms of safety, feasibility and oncological outcomes with improved patient satisfaction as measured by nipple sensation and patient reported outcomes.

Official Title

Safety and Feasibility of Robotic Single-port (SP) Nipple Sparing Mastectomy: A Single Institution, Single Arm Pilot Trial

Quick Facts

Study Start:2022-03-08
Study Completion:2026-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05245812

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. * Candidates for open nipple sparing mastectomy, per standard of care with regards to anatomic factors and tumor location including: nipple sparing resection and resection OR prophylactic mastectomy for risk reduction OR treatment of ductal carcinoma in-situ or clinically node negative cT1-T3 breast cancer
  2. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  1. * Inability to provide informed consent
  2. * Pregnant or nursing women
  3. * Patients with:
  4. * Inflammatory breast cancer
  5. * Skin involvement with tumor
  6. * Pre-operative diagnosis of Nipple Areolar Complex (NAC) tumor involvement
  7. * Grade 3 or higher nipple ptosis
  8. * Contraindicated for general anesthesia or surgery
  9. * Heavy current smoking history (defined as \> 20 cigarettes per day)

Contacts and Locations

Study Contact

Deborah Farr, MD, FACS
CONTACT
214-648-4133
Deborah.Farr@UTSouthwestern.edu

Principal Investigator

Deborah Farr, MD, FACS
PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center

Study Locations (Sites)

UT Southwestern
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: Deborah Farr, MD

  • Deborah Farr, MD, FACS, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

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 Date2022-03-08
Study Completion Date2026-02

Study Record Updates

Study Start Date2022-03-08
Study Completion Date2026-02

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Cancer
  • High Risk of Breast Cancer