da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures

Overview

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.

Full Title of Study: “A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Colorectal Procedures for Benign and Malignant Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2021

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

Interventions

  • Device: Robotic Assisted Surgery
    • da Vinci SP Surgical System, instruments, and accessories in complex colorectal procedures such as low anterior resection procedure with or without total mesorectal excision

Arms, Groups and Cohorts

  • Other: Single arm
    • Colorectal procedure will be performed by da Vinci SP® Surgical System

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • Age ≥ 18 years
  • BMI ≤35
  • Candidate for single-port robotic-assisted surgery for colorectal disease
  • Malignant tumor or neoplastic polyps that is/are amenable for low anterior resection with or without total mesorectal excision or tumor specific total mesorectal excision depending on tumor height
  • ASA ≤3
  • Willing and able to provide a written informed consent document.
  • Willing and able to comply with the study protocol requirements

Exclusion Criteria

  • Clinical or radiological evidence of metastatic disease
  • Life expectancy less than 6 months.
  • Cancer of the anal canal requiring an abdominoperineal resection.
  • Severely symptomatic tumors
  • Prior history of colon or rectal resection for benign or malignant causes, excluding appendectomy.
  • Preoperative colonoscopy demonstrating synchronous colorectal cancer
  • History of inflammatory bowel disease.
  • History of prior prostatectomy.
  • Known bleeding or clotting disorder.
  • Uncontrolled illness
  • Contraindicated for general anesthesia or surgery.
  • Subject belongs to vulnerable population.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Intuitive Surgical
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • David Larson, MD, MBA, Principal Investigator, Mayo Clinic
  • Overall Contact(s)
    • Marianna Finkel, 408-523-1018, Marianna.Finkel@Intusurg.com

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