A Prospective Investigation of the ColubrisMX ELS System

NCT ID: NCT04192565

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-13
• Study Completion Date: 2021-04-15

Brief Summary

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

Detailed Description

Endoscopic resection of small polyps is performed routinely through conventional outpatient colonoscopy. Larger polyps or incipient tumors can be excised with endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD). These minimally invasive procedures have been shown to be viable alternatives to conventional surgical resections with less risk of complications, shorter hospital stay and lower costs.

Both flexible endoscopic and open/laparoscopic surgical approaches have procedural limitations that can have considerable impact on patient care. Traditional endoscopic tools have technical inadequacies that may 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 risk of complications (such as surgical site infection), increased pain and blood loss, longer recovery, and surgical scars. The objective of this clinical study is to assess the safety and efficacy of the ColubrisMX Endoluminal Surgical (ELS) System, a new robotic technology designed to assist the physician with precision, flexibility, and control during endoluminal removal of colorectal lesions.

Conditions

Colorectal Neoplasms; Colorectal Polyp; Colorectal Adenoma; Colorectal Adenomatous Polyp

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robotic Transanal Endoluminal Resection

Robotic Transanal Endoluminal Resection of Colorectal Lesions

Group Type: EXPERIMENTAL

ColubrisMX Endoluminal Surgical (ELS) System

Intervention Type: DEVICE

Robotic Transanal Endoluminal Resection of Colorectal Lesions using the ColubrisMX Endoluminal Surgical (ELS) System

Interventions

ColubrisMX Endoluminal Surgical (ELS) System

Robotic Transanal Endoluminal Resection of Colorectal Lesions using the ColubrisMX Endoluminal Surgical (ELS) System

Intervention Type: DEVICE

Eligibility Criteria

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.

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

Intraoperative

1. Existing stricture or anatomical blockage in lower GI tract preventing overtube from reaching desired position.

2. Disease is more extensive and not amenable to standard ESD

3. Inadequate bowel prep

4. Complex anatomical findings not feasible for endoscopic approach

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Faculdade de Medicina do ABC

OTHER

Sponsor Role: collaborator

ColubrisMX

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eduardo Grecco, MD

Role: PRINCIPAL_INVESTIGATOR

Faculdade de Medicina do ABC

Locations

Faculdade de Medicina do ABC

Santo André, São Paulo, Brazil

Countries

Brazil

Other Identifiers

CMX-CSP-CS002

Identifier Type: -

Identifier Source: org_study_id