๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-12-17

Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing Mastectomy (NCT03892980)

A Prospective, Multicenter Investigation of the da Vinciยฎ Surgical Systems in Nipple Sparing Mastectomy (NSM) Procedures

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Intuitive Surgical

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

This study evaluates the safety and effectiveness of the da Vinci Surgical Systems in prophylactic Nipple Sparing Mastectomy procedures.

Who can join: Review the eligibility criteria below.

Location: Mayo Clinic Florida โ€” Jacksonville, Florida

Age range: 18 Years to 80 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (6 Sites)

  • Mayo Clinic Florida โ€” Jacksonville, Florida
  • NorthShore University Health System โ€” Evanston, Illinois
  • Mayo Clinic โ€” Rochester, Minnesota
  • Northwell Health โ€” New Hyde Park, New York
  • University of Pennsylvania โ€” Philadelphia, Pennsylvania
  • MD Anderson Cancer Center โ€” Houston, Texas

๐Ÿ“ž Contact the Study Coordinator

Phone: (800) 664-4580

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ 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 ยง 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.

More studies in Nipple Sparing Mastectomy

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—