🏛️ Verified NIH Record • Updated 2026-05-07

da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures (NCT04403022)

A Prospective, Multi-Center Investigation of the da Vinci SP® Surgical System in Colorectal Procedures for Benign and Malignant Disease

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Intuitive Surgical

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

To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in a complex colorectal procedure such as low anterior resections or right colectomy.

Who can join: Review the eligibility criteria below.

Location: Adventist Health System/Sunbelt — Orlando, Florida

Age range: 18 Years

🧪 Interventions in This Study

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

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (9 Sites)

  • Adventist Health System/Sunbelt — Orlando, Florida
  • Henry Ford — Detroit, Michigan
  • Mayo Clinic — Rochester, Minnesota
  • MountianView Hospital — Las Vegas, Nevada
  • Allegheny General Hospital — Pittsburgh, Pennsylvania
  • Houston Methodist Research Institute — Houston, Texas
  • MultiCare - Tacoma — Tacoma, Washington
  • Ulsan University Hospital — Ulsan, Dong-gu
  • Ewha Womans University College of Medicine — Seoul, Gangseo-gu

💰 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.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  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.
🏛️ View Official NIH Record ↗