Status:
RECRUITING
Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy
Lead Sponsor:
Deborah Farr, MD
Conditions:
Breast Cancer
High Risk of Breast Cancer
Eligibility:
FEMALE
18-80 years
Phase:
NA
Brief Summary
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 perfo...
Detailed Description
rNSM using the multi-port robotic platform followed by standard of care open breast reconstruction has been done successfully at multiple institutions worldwide with comparable, if not superior outcom...
Eligibility Criteria
Inclusion
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion
- Inability to provide informed consent
- Pregnant or nursing women
- Patients with:
- Inflammatory breast cancer
- Skin involvement with tumor
- Pre-operative diagnosis of Nipple Areolar Complex (NAC) tumor involvement
- Grade 3 or higher nipple ptosis
- Contraindicated for general anesthesia or surgery
- Heavy current smoking history (defined as \> 20 cigarettes per day)
Key Trial Info
Start Date :
March 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05245812
Start Date
March 8 2022
End Date
February 1 2026
Last Update
July 28 2025
Active Locations (1)
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1
UT Southwestern
Dallas, Texas, United States, 75390