da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures

  • STATUS
    Recruiting
  • End date
    Dec 6, 2027
  • participants needed
    60
  • sponsor
    Intuitive Surgical
Updated on 4 October 2022
low anterior resection
total mesorectal excision

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.

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

Details
Condition Colon cancer; rectal cancer, Benign or Malignant Rectal or Colon Tumors, Colon Cancer Screening, Colorectal Cancer, Rectal Cancer, rectal carcinoma
Treatment Robotic Assisted Surgery
Clinical Study IdentifierNCT04403022
SponsorIntuitive Surgical
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years
BMI 35
Candidate for single-port robotic-assisted surgery for colorectal disease
Malignant tumor or neoplastic polyps located within 15 cm from anal verge that is/are amenable for low anterior resection with or without total mesorectal excision or tumor specific total mesorectal excision depending on tumor height; or benign or malignant right colon disease
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
Subjects with threatened resection margins ( 1mm) on MRI
Subjects with major concomitant procedures (eg. hepatectomaies, other intestinal resections) or emergent case
Subjects undergoing both LAR/TME and right colectomy during the same operation
History of inflammatory bowel disease
History of prior prostatectomy
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 repair
Subject belongs to vulnerable population
Subject is pregnant or suspected to be pregnant
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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