A Prospective Investigation of the ColubrisMX ELS System

A Prospective Investigation of the ColubrisMX Endoluminal Surgical (ELS) System

This study is a prospective, single-arm, open-label, multi-center, feasibility study to evaluate the safety and efficacy of ColubrisMX ELS System in patients undergoing transanal endoluminal procedures, specifically colorectal Endoscopic Submucosal Dissection.

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms; Colorectal Adenoma; Colorectal Polyp; Colorectal Adenomatous Polyp
• Intervention / Treatment: Device: Robotic Endoluminal Resection

Detailed Description

Current treatment options for colorectal lesions most often include flexible endoscopy or open/laparoscopic surgery. Both approaches have procedural limitations that can have considerable impact on patient care. Traditional endoscopic tools have technical inadequacies, ones that inhibit the physician's ability to complete more complex tasks consistent with a surgical technique. Conversely a traditional open or laparoscopic surgical approach involves increased chance of complications (such as surgical site infection), more pain & blood loss, longer recovery and larger surgical scars.

This clinical study proposes the use of an endoluminal robotic technology that is designed to improve patient outcomes for colorectal lesions. This system allows physicians to perform many types of complex endoluminal procedures with more precision, flexibility, and control than that of conventional endoscopic, open or laparoscopic surgical techniques. Using this robotic system, surgeons can perform delicate and complex endoluminal procedures that may have been difficult or impossible with other methods, and could have positive impact on outcomes, recovery time, and overall patient care.

Patients will undergo the procedure using the ColubrisMX ELS System, and its initial safety and efficacy outcomes will be assessed intraoperatively and postoperatively at discharge and days 7 and 30.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • Santo André, Sao Paulo, Brazil, 09060-870
      • Faculdade de Medicina do ABC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

13 INCLUSION CRITERIA

All of the following criteria must be present to be eligible for the study:

1. Aged 18-75 years
2. BMI ≤ 35 kg/m2
3. Patient agrees to participate in the study by giving signed informed consent
4. Benign lesions of the rectum, such as adenoma, submucosal nodule, or polyp
5. Mucosal neoplasm
6. Eligible to undergo standard endoscopic submucosal dissection.
7. Patient reviewed and approved by Local Oncology Committee to undergo robotic procedure.

14 EXCLUSION CRITERIA

Patients will be excluded from the study if any of the following criteria are present:

Preoperative

1. Anatomy unsuitable for endoscopic visualization or endoluminal surgery
2. Extensive previous surgery in the lower GI tract
3. Prior radiation treatment for colorectal cancer
4. Patient with distant metastases
5. Untreated active infection
6. Vulnerable population (e.g., prisoners, mentally disabled)
7. Severe concomitant illness (i.e., cancer) that drastically shortens life expectancy or increases risk of therapeutic interventions
8. Breastfeeding or pregnant, or intend to become pregnant during the course of the study
9. Currently enrolled in or discontinued within the last 30 days from a clinical trial of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
10. In the opinion of the Investigator, the patient is unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.
11. Patients with immunosuppression drugs (chemotherapy) due to an increase potential infection and poor healing
12. Patients with a high cardiac or pulmonary risk (these patients require clearance from a cardiologist and pulmonologist)
13. Preoperative blood thinner i.e., coumadin or heparin.
14. Obstructing rectal cancer
15. History of inflammatory bowel disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Robotic Endoluminal Resection; Robotic resection of mucosal lesions of the colon and rectum	Device: Robotic Endoluminal Resection; Robotic Resection of mucosal neoplasms in the colon and rectum using the ColubrisMX ELS system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of success	Percentage of patients with no conversion during surgery and no major complications (Clavien-Dindo ≥ 3 complication rate)	24 hours post-op
Rate of Conversion	Percentage of patients with a change in treatment plan to a conventional open or laparoscopic procedure	Intraoperative
Complication rate (%)	Percentage of patients having Clavien-Dindo ≥ 3	Intraoperatively and postoperatively at Days 7 and 30.

Collaborators and Investigators

• Sponsor: ColubrisMX
• Collaborators: Faculdade de Medicina do ABC
• Investigators: Principal Investigator: Eduardo Grecco, MD, Faculdade de Medicina do ABC

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 9, 2020
• Primary Completion (ACTUAL): March 29, 2021
• Study Completion (ACTUAL): March 29, 2021

Study Registration Dates

• First Submitted: December 6, 2019
• First Submitted That Met QC Criteria: December 6, 2019
• First Posted (ACTUAL): December 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2021
• Last Update Submitted That Met QC Criteria: June 30, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Colorectal Neoplasms; Colorectal Polyp; Colorectal Adenoma
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Adenoma; Polyps; Adenomatous Polyps
• Other Study ID Numbers: CMX-CSP-CS002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes