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A Prospective Investigation of the ColubrisMX ELS System

Primary Purpose

Colorectal Neoplasms, Colorectal Polyp, Colorectal Adenoma

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Robotic Endoluminal Resection

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Colorectal Neoplasms, Colorectal Polyp, Colorectal Adenoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

13 INCLUSION CRITERIA

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

Aged 18-75 years
BMI ≤ 35 kg/m2
Patient agrees to participate in the study by giving signed informed consent
Benign lesions of the rectum, such as adenoma, submucosal nodule, or polyp
Mucosal neoplasm
Eligible to undergo standard endoscopic submucosal dissection.
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

Anatomy unsuitable for endoscopic visualization or endoluminal surgery
Extensive previous surgery in the lower GI tract
Prior radiation treatment for colorectal cancer
Patient with distant metastases
Untreated active infection
Vulnerable population (e.g., prisoners, mentally disabled)
Severe concomitant illness (i.e., cancer) that drastically shortens life expectancy or increases risk of therapeutic interventions
Breastfeeding or pregnant, or intend to become pregnant during the course of the study
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
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.
Patients with immunosuppression drugs (chemotherapy) due to an increase potential infection and poor healing
Patients with a high cardiac or pulmonary risk (these patients require clearance from a cardiologist and pulmonologist)
Preoperative blood thinner i.e., coumadin or heparin.
Obstructing rectal cancer
History of inflammatory bowel disease

Sites / Locations

Faculdade de Medicina do ABC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Robotic Endoluminal Resection

Arm Description

Robotic resection of mucosal lesions of the colon and rectum

Outcomes

Primary Outcome Measures

Rate of success

Percentage of patients with no conversion during surgery and no major complications (Clavien-Dindo ≥ 3 complication rate)

Rate of Conversion

Percentage of patients with a change in treatment plan to a conventional open or laparoscopic procedure

Complication rate (%)

Percentage of patients having Clavien-Dindo ≥ 3

Secondary Outcome Measures

Full Information

NCT ID

NCT04192565

First Posted

December 6, 2019

Last Updated

June 30, 2021

Sponsor

ColubrisMX

Collaborators

Faculdade de Medicina do ABC

1. Study Identification

Unique Protocol Identification Number

NCT04192565

Brief Title

A Prospective Investigation of the ColubrisMX ELS System

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

September 9, 2020 (Actual)

Primary Completion Date

March 29, 2021 (Actual)

Study Completion Date

March 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ColubrisMX

Collaborators

Faculdade de Medicina do ABC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Neoplasms, Colorectal Polyp, Colorectal Adenoma, Colorectal Adenomatous Polyp

Keywords

Colorectal Neoplasms, Colorectal Polyp, Colorectal Adenoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Robotic Endoluminal Resection

Arm Type

Experimental

Arm Description

Robotic resection of mucosal lesions of the colon and rectum

Intervention Type

Device

Intervention Name(s)

Robotic Endoluminal Resection

Intervention Description

Robotic Resection of mucosal neoplasms in the colon and rectum using the ColubrisMX ELS system

Primary Outcome Measure Information:

Title

Rate of success

Description

Percentage of patients with no conversion during surgery and no major complications (Clavien-Dindo ≥ 3 complication rate)

Time Frame

24 hours post-op

Title

Rate of Conversion

Description

Percentage of patients with a change in treatment plan to a conventional open or laparoscopic procedure

Time Frame

Intraoperative

Title

Complication rate (%)

Description

Percentage of patients having Clavien-Dindo ≥ 3

Time Frame

Intraoperatively and postoperatively at Days 7 and 30.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

13 INCLUSION CRITERIA All of the following criteria must be present to be eligible for the study: Aged 18-75 years BMI ≤ 35 kg/m2 Patient agrees to participate in the study by giving signed informed consent Benign lesions of the rectum, such as adenoma, submucosal nodule, or polyp Mucosal neoplasm Eligible to undergo standard endoscopic submucosal dissection. 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 Anatomy unsuitable for endoscopic visualization or endoluminal surgery Extensive previous surgery in the lower GI tract Prior radiation treatment for colorectal cancer Patient with distant metastases Untreated active infection Vulnerable population (e.g., prisoners, mentally disabled) Severe concomitant illness (i.e., cancer) that drastically shortens life expectancy or increases risk of therapeutic interventions Breastfeeding or pregnant, or intend to become pregnant during the course of the study 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 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. Patients with immunosuppression drugs (chemotherapy) due to an increase potential infection and poor healing Patients with a high cardiac or pulmonary risk (these patients require clearance from a cardiologist and pulmonologist) Preoperative blood thinner i.e., coumadin or heparin. Obstructing rectal cancer History of inflammatory bowel disease

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eduardo Grecco, MD

Organizational Affiliation

Faculdade de Medicina do ABC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculdade de Medicina do ABC

City

Santo André

State/Province

Sao Paulo

ZIP/Postal Code

09060-870

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Prospective Investigation of the ColubrisMX ELS System

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