A Prospective Investigation of the ColubrisMX ELS System

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04192565
• Other study ID #: CMX-CSP-CS002
• Status: Completed
• Phase: N/A
• Start date: September 9, 2020
• Est. completion date: March 29, 2021

Study information

• Verified date: June 2021
• Source: ColubrisMX
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 29, 2021
• Est. primary completion date: March 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adenomatous Polyps
• Colorectal Adenoma
• Colorectal Adenomatous Polyp
• Colorectal Neoplasms
• Colorectal Polyp
• Polyps

Intervention

Device:
• Robotic Endoluminal Resection
Robotic Resection of mucosal neoplasms in the colon and rectum using the ColubrisMX ELS system

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina do ABC	Santo André	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
ColubrisMX	Faculdade de Medicina do ABC

Country where clinical trial is conducted

Brazil, 

Outcome

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