da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer; Benign or Malignant Rectal or Colon Tumors
• Intervention / Treatment: Device: Robotic Assisted Surgery

Detailed Description

Primary Performance:

• The primary performance endpoint will be assessed as the ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach. Conversion* to an alternate approach comprises conversion to open, multiport laparoscopic**, multiport robotic or hand-assisted§ approach requiring undocking of the da Vinci SP Surgical System in order to complete the planned procedure using the alternate approach.

  • Performing an extracorporeal anastomosis is not considered a conversion ** Use of additional assistant laparoscopic port(s) is not considered a conversion § Laparoscopic or robotic with hand assistance

Primary Safety:

• The primary safety endpoint will be assessed as the incidence of all intraoperative and post-operative adverse events that occur through the 42-day follow-up period

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alex Valencia, MS; Phone Number: #6109317 408-523-8181; Email: alex.valencia2@intusurg.com
• Study Contact Backup: Name: Janet Shelly; Email: Janet.Shelley@intusurg.com

Study Locations

• Korea, Republic of
  • Dong-gu
    • Ulsan, Dong-gu, Korea, Republic of, 25 Daehakbyeongwon-ro
      • Ulsan University Hospital
  • Gangseo-gu
    • Seoul, Gangseo-gu, Korea, Republic of, Gonghang-daero
      • Ewha Womans University College of Medicine
• United States
  • Florida
    • Orlando, Florida, United States, 32803
      • Adventist Health System/Sunbelt
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • MountianView Hospital
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Research Institute
  • Washington
    • Tacoma, Washington, United States, 98405
      • MultiCare - Tacoma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single arm; Colorectal procedure will be performed by da Vinci SP® Surgical System	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance	Performance defined as ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach.	IntraOperative period
Adverse Events Rates	Safety defined as the incidence of all intraoperative and post-operative adverse events that occur through the 42-day follow-up period	Intraoperative through the 42-day postoperative period

Collaborators and Investigators

• Sponsor: Intuitive Surgical
• Investigators: Study Director: Kathryn Wine, Medical Affairs Director

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2021
• Primary Completion (Actual): September 30, 2023
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Actual): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: dV SP - CR-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes