da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures

NCT04403022 | Active Not Recruiting FDA Device

• 1 other identifier: dV SP - CR-01
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 9

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.

Conditions

Colorectal Cancer; Benign or Malignant Rectal or Colon Tumors

Outcome Measures

Primary Outcomes (2)

• Performance

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

  IntraOperative period

• 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

Study Arms (1)

Single arm

OTHER

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

Device: Robotic Assisted Surgery

Interventions

Robotic Assisted Surgery DEVICE

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

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Intuitive Surgical: lead

Study Sites (9)

Adventist Health System/Sunbelt

Orlando, Florida, 32803, United States

Location

Henry Ford

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MountianView Hospital

Las Vegas, Nevada, 89128, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Houston Methodist Research Institute

Houston, Texas, 77030, United States

Location

MultiCare - Tacoma

Tacoma, Washington, 98405, United States

Location

Ulsan University Hospital

Ulsan, Dong-gu, 25 Daehakbyeongwon-ro, South Korea

Location

Ewha Womans University College of Medicine

Seoul, Gangseo-gu, Gonghang-daero, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Robotic Surgical Procedures

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Surgery, Computer-Assisted; Surgical Procedures, Operative; Robotics; Automation; Technology; Technology, Industry, and Agriculture

Study Officials

• Madhu L Gorrepati

  Clinical Affairs Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 27, 2020
• Study Start: June 3, 2021
• Primary Completion: September 30, 2023
• Study Completion (Estimated): November 30, 2028
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); KR (2)