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Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

NCT05245812 · University of Texas Southwestern Medical Center
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Official title
Safety and Feasibility of Robotic Single-port (SP) Nipple Sparing Mastectomy: A Single Institution, Single Arm Pilot Trial
About this study
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 outcomes to an open surgical approach. This study explores this procedure with the Da Vinci SP robot with pre-pectoral reconstruction with acellular dermal matrix. The patients will be evaluated per standard of care post-operative visits at 2 weeks, 1 month, and every 6 months for five years post operatively for subjective patient satisfaction and objectively for post-operative nipple sensation. The patients will be monitored longitudinally for oncologic outcomes including the presence of a new breast cancer and/or breast cancer recurrence. Patients will be monitored for any complications related to rNSM and the use of ADM in expander and implant-based breast reconstruction. Investigational Device: The da Vinci SP Surgical System, Model SP1098 is a software-controlled, electro- mechanical system designed for surgeons to perform single port minimally invasive surgery. The Model SP1098 Surgical System consists of a Surgeon Console, a Patient Cart, and a Vision Cart, and is used with a Camera Instrument, EndoWrist SP Instruments, and Accessories. Indications for Use: The da Vinci SP Surgical System, Model SP1098 is cleared for use in urologic surgical procedures that are appropriate for a single-port approach and transoral otolaryngology procedures restricted to T1 and T2 tumors. This investigational study will evaluate device usage in nipple sparing mastectomy (NSM) procedures.
Eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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)
Study design
Enrollment target: 90 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-03-08
Estimated completion: 2027-02
Last updated: 2026-03-20
Interventions
Device: da Vinci SP Surgical System
Primary outcomes
  • Number of participants who complete single port nipple sparing mastectomy (SPrNSM) (Date of surgery (Day 1))
  • Incidence of perioperative complications (30 days following surgery)
Sponsor
Deborah Farr, MD · other
Contacts & investigators
ContactDeborah Farr, MD, FACS · contact · Deborah.Farr@UTSouthwestern.edu · 214-648-4133
InvestigatorDeborah Farr, MD, FACS · principal_investigator, University of Texas Southwestern Medical Center
All locations (1)
UT SouthwesternRecruiting
Dallas, Texas, United States
Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy · TrialPath