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Active, not recruiting Not applicable

da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures

NCT04403022 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2021-06-03
Last updated
2026-10-01

Condition(s) studied

Colorectal CancerBenign or Malignant Rectal or Colon Tumors

Investigational drug(s) / intervention(s)

Robotic Assisted Surgery

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years * BMI ≤ 35 * Candidate for single-port robotic-assisted surgery for low anterior resection with or without total mesorectal excision or right colectomy procedures * ASA ≤ 3 * Willing and able to provide a written informed consent document * Willing and able to comply with the study protocol requirements including perioperative follow-up examinations at 14 days, 42 days post operatively, and post-market long-term follow-up on an annual basis through 5 years Exclusion Criteria: * Clinical or radiological evidence of metastatic disease * Life expectancy less than 6 months * Cancer of the anal canal requiring an abdominoperineal resection * Subjects with threatened mesorectal margins (≤1 mm) on MRI or ultrasound (for LAR ONLY) * Subjects with planned major concomitant procedures (eg. hepatectomaies, other intestinal resections) or emergent case * Subjects undergoing both LAR/TME and right colectomy during the same operation * Preoperative colonoscopy demonstrating synchronous colorectal cancer * History of inflammatory bowel disease * Subject has a known bleeding or clotting disorder * Uncontrolled illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Subject is contraindicated for general anesthesia or surgery * Subject had prior incisional hernia with mesh repair * Subject belongs to vulnerable population * Subject is pregnant or suspected to be pregnant Intraoperative Exclusion Criteria: • Subject presents with adhesions or scarring in the pelvis which in the opinion of the investigator limits the ability to perform the minimally invasive procedure

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)

FacilityCityRegionStatus
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

More Intuitive Surgical trials in South Korea

Official registry record

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