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da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures

Primary Purpose

Colorectal Cancer, Benign or Malignant Rectal or Colon Tumors

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Robotic Assisted Surgery
Sponsored by
Intuitive Surgical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Adventist Health System/Sunbelt
  • Henry Ford
  • Mayo Clinic
  • MountianView Hospital
  • Allegheny General Hospital
  • Houston Methodist Research Institute
  • MultiCare - Tacoma
  • Ulsan University Hospital
  • Ewha Womans University College of Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single arm

Arm Description

Colorectal procedure will be performed by da Vinci SP® Surgical System

Outcomes

Primary Outcome Measures

Performance
Performance defined as ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach.
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

Secondary Outcome Measures

Full Information

First Posted
May 14, 2020
Last Updated
July 14, 2023
Sponsor
Intuitive Surgical
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1. Study Identification

Unique Protocol Identification Number
NCT04403022
Brief Title
da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures
Official Title
A Prospective, Multi-Center Investigation of the da Vinci SP® Surgical System in Colorectal Procedures for Benign and Malignant Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 3, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
November 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intuitive Surgical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Benign or Malignant Rectal or Colon Tumors

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Other
Arm Description
Colorectal procedure will be performed by da Vinci SP® Surgical System
Intervention Type
Device
Intervention Name(s)
Robotic Assisted Surgery
Intervention Description
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 Measure Information:
Title
Performance
Description
Performance defined as ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach.
Time Frame
IntraOperative period
Title
Adverse Events Rates
Description
Safety defined as the incidence of all intraoperative and post-operative adverse events that occur through the 42-day follow-up period
Time Frame
Intraoperative through the 42-day postoperative period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn Wine
Organizational Affiliation
Medical Affairs Director
Official's Role
Study Director
Facility Information:
Facility Name
Adventist Health System/Sunbelt
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Henry Ford
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
MountianView Hospital
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Houston Methodist Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
MultiCare - Tacoma
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Ulsan University Hospital
City
Ulsan
State/Province
Dong-gu
ZIP/Postal Code
25 Daehakbyeongwon-ro
Country
Korea, Republic of
Facility Name
Ewha Womans University College of Medicine
City
Seoul
State/Province
Gangseo-gu
ZIP/Postal Code
Gonghang-daero
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures

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