Who is eligible for clinical trial NCT05245812?

Participants must meet protocol criteria for Breast Cancer. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05245812 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-03-17

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy (NCT05245812)

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Deborah Farr, MD

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (2 items) and avoid the listed exclusions (10 items).

Location: UT Southwestern — Dallas, Texas

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

UT Southwestern — Dallas, Texas

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗