da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04403022
• Other study ID #: dV SP - CR-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 3, 2021
• Est. completion date: November 30, 2028

Study information

• Verified date: June 2024
• Source: Intuitive Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: November 30, 2028
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Cancer

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Ewha Womans University College of Medicine	Seoul	Gangseo-gu
Korea, Republic of	Ulsan University Hospital	Ulsan	Dong-gu
United States	Henry Ford	Detroit	Michigan
United States	Houston Methodist Research Institute	Houston	Texas
United States	MountianView Hospital	Las Vegas	Nevada
United States	Adventist Health System/Sunbelt	Orlando	Florida
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	MultiCare - Tacoma	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Countries where clinical trial is conducted

United States,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance	Performance defined as ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach.	IntraOperative period
Primary	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