da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures

Not Applicable

Active, not recruiting

• Conditions: Benign or Malignant Rectal or Colon Tumors; Colorectal Cancer
• Interventions: Device: Robotic Assisted Surgery

• Registration Number: NCT04403022
• Lead Sponsor: 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.

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

Study Timeline

• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-05-21
• Study First Posted: 2020-05-27
• Study Start: 2021-06-03
• Primary Completion: 2023-09-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-21
• Study Completion: 2028-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Robotic Assisted Surgery	Colorectal procedure will be performed by da Vinci SP® Surgical System

Primary Outcome Measures

Name	Time	Method
Performance	IntraOperative period	Performance defined as ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach.
Adverse Events Rates	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

Trial Locations

Locations (9)

Ewha Womans University College of Medicine; 🇰🇷 Seoul, Gangseo-gu, Korea, Republic of

Ulsan University Hospital; 🇰🇷 Ulsan, Dong-gu, Korea, Republic of

MultiCare - Tacoma; 🇺🇸 Tacoma, Washington, United States

MountianView Hospital; 🇺🇸 Las Vegas, Nevada, United States

Adventist Health System/Sunbelt; 🇺🇸 Orlando, Florida, United States

Henry Ford; 🇺🇸 Detroit, Michigan, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Houston Methodist Research Institute; 🇺🇸 Houston, Texas, United States