da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures

Sponsor

Intuitive Surgical (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04403022

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Benign or Malignant Rectal or Colon Tumors	Device: Robotic Assisted Surgery	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jun 3, 2021

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Oct 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Other: Single arm Colorectal procedure will be performed by da Vinci SP® Surgical System	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

Arm

Intervention/Treatment

Other: Single arm

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Adventist Health System/Sunbelt	Orlando	Florida	United States	32803
2	Mayo Clinic	Rochester	Minnesota	United States	55905
3	Houston Methodist Research Institute	Houston	Texas	United States	77030

Sponsors and Collaborators

Intuitive Surgical

Investigators

Study Director: Katheryn Wine, Medical Affairs Director

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Intuitive Surgical

ClinicalTrials.gov Identifier:

NCT04403022

Other Study ID Numbers:

dV SP - CR-01

First Posted:

May 27, 2020

Last Update Posted:

Aug 10, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Colonic Neoplasms

Study Results

No Results Posted as of Aug 10, 2022