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da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04403022
Recruitment Status : Recruiting
First Posted : May 27, 2020
Last Update Posted : May 31, 2023
Information provided by (Responsible Party):
Intuitive Surgical

Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Benign or Malignant Rectal or Colon Tumors Device: Robotic Assisted Surgery Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Prospective, Multi-Center Investigation of the da Vinci SP® Surgical System in Colorectal Procedures for Benign and Malignant Disease
Actual Study Start Date : June 3, 2021
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : October 2028

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

  2. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04403022

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Contact: Alex Valencia, MS 408-523-8181 ext #6109317
Contact: Janet Shelly

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United States, Florida
Mayo Clinic - Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Amit Merchea, MD    904-953-2000      
Principal Investigator: Amit Merchea, MD         
Adventist Health System/Sunbelt Completed
Orlando, Florida, United States, 32803
United States, Minnesota
Mayo Clinic Active, not recruiting
Rochester, Minnesota, United States, 55905
United States, Nevada
MountianView Hospital Recruiting
Las Vegas, Nevada, United States, 89128
Contact: Garrett Friedman, MD    702-962-2300      
Principal Investigator: Garrett Friedman, MD         
United States, Pennsylvania
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: James McCormick, DO    412-359-3901      
Principal Investigator: James McCormick, DO         
United States, Texas
Houston Methodist Research Institute Active, not recruiting
Houston, Texas, United States, 77030
United States, Washington
MultiCare - Tacoma Recruiting
Tacoma, Washington, United States, 98405
Contact: Laila Rashidi, MD    253-301-5050      
Principal Investigator: Laila Rashidi, MD         
Korea, Republic of
Ulsan University Hospital Recruiting
Ulsan, Dong-gu, Korea, Republic of, 25 Daehakbyeongwon-ro
Contact: Song soo Yang, MD         
Ewha Womans University College of Medicine Recruiting
Seoul, Gangseo-gu, Korea, Republic of, Gonghang-daero
Contact: Gyoung Tae Noh, MD         
Sponsors and Collaborators
Intuitive Surgical
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Study Director: Kathryn Wine Medical Affairs Director
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Responsible Party: Intuitive Surgical Identifier: NCT04403022    
Other Study ID Numbers: dV SP - CR-01
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: May 31, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases