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

Status Active, not recruiting

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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Cancer

• NCT number: NCT04403022
• Study type: Interventional
• Source: Intuitive Surgical
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 3, 2021
• Completion date: November 30, 2028