Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

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 hyp

Trial Details

NCT ID
NCT05245812
Phase
NA
Sponsor
Deborah Farr, MD
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • da Vinci SP Surgical System
Locations (sample)
  • Dallas, Texas, United States|32.78306,-96.80667

Key Eligibility Criteria

  • Candidates for open nipple sparing mastectomy, per standard of care with regards to anatomic factors and tumor location including: nipple sparing r…
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

For full eligibility, visit ClinicalTrials.gov.

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