A Prospective Investigation of the ColubrisMX ELS System

Endoscopic Resection of Colorectal Lesions with ColubrisMX Endoluminal Surgical System (ELS for Its Initials in English), Prospective Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms; Colorectal Adenoma; Colorectal Polyp; Colorectal Adenomatous Polyp
• Intervention / Treatment: Device: ColubrisMX Endoluminal Surgical (ELS) System

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• 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: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic Transanal Endoluminal Resection; Robotic Transanal Endoluminal Resection of Colorectal Lesions	Device: ColubrisMX Endoluminal Surgical (ELS) System; Robotic Transanal Endoluminal Resection of Colorectal Lesions using the ColubrisMX Endoluminal Surgical (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 ≥ III complication rating) for 24 hours post-op.	24 hours post-op
Rate of conversions (%)	Percentage of patients with a change in treatment plan to a conventional open or laparoscopic procedure.	Intraoperative
Estimated blood loss (mL)	Estimated amount of intraoperative blood loss (up to the point of needing transfusion).	Intraoperative
Operative time (min)	Duration from transanal insertion of the robotic flexible overtube to final removal of the flexible overtube from the anal verge.	Intraoperative
Patients requiring transfusion (%)	Percentage of patients requiring transfusion during surgery.	Intraoperative
Complication rate (%)	Percentage of patients having Clavien-Dindo ≥ III intraoperatively or postoperatively at Days 7, 30, or 60.	60 Days
Readmission rate (%)	Percentage of patients with readmission that can be linked to colorectal submucosal dissection.	60 Days
Major Adverse Events (MAE) during the first 60 days	Freedom from procedural-related MAE, defined as a combined clinical endpoint of death or reoperation for failed surgical repair.	60 Days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
En bloc resection rate (%)	Percentage of samples dissected en bloc, as assessed by the pathologist during postoperative assessment.	Intraoperative
Rate of positive surgical lateral margins (PSLM) (%)	The number and percentage of subjects with PSLM will be presented separately by subjects undergoing rectal ESD.	60 Days
Rate of perforations repaired operatively (%)	Rate of perforations requiring repair through open or laparoscopic surgery.	Intraoperative
Rate of perforations requiring repair through open or laparoscopic surgery (%)	Rate of perforations requiring repair through open or laparoscopic surgery	Intraoperative
Rate of delayed perforations (%)	Perforations that present 10 to 24 hours after procedure with clinical signs and symptoms of peritonitis.	60 Days
Adverse Events	Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in patients, users, or other persons, whether related to the investigational medical device.	60 Days
Vital Signs	Changes in vital signs from baseline to post-operative Days 7, 30 and 60.	60 Days
Laboratory Assessments	Changes in laboratory parameters and normal/abnormal status changes in laboratory parameters from baseline to post-operative Days 7, 30 and 60.	60 Days

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 13, 2020
• Primary Completion (Actual): April 15, 2021
• Study Completion (Actual): April 15, 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): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 13, 2024
• Last Verified: September 1, 2024

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