A Prospective Investigation of the ColubrisMX ELS System

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: Robotic Endoluminal Resection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic Endoluminal Resection<br>Robotic resection of mucosal lesions of the colon and rectum | Device: Robotic Endoluminal Resection<br>* Robotic Resection of mucosal neoplasms in the colon and rectum using the ColubrisMX ELS system<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Neoplasms, Colorectal Polyp, Colorectal Adenoma