da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures
Condition(s) studied
Investigational drug(s) / intervention(s)
Robotic Assisted Surgery: da Vinci SP Surgical System, instruments, and accessories in complex colorectal procedures such as low anterior resection procedure or right colectomy with or without total mesorectal excision
Study summary
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.
Eligibility
Primary outcome measure(s)
- Rate of Conversion — IntraOperative period
Performance defined as ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach. - Major Adverse Events Rates — Intraoperative through the 42-day postoperative period
Safety defined as the incidence of all major adverse events that occur through the 42-day follow-up period
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04403022 on ClinicalTrials.gov ↗ ← All trials in South Korea