Transanal Resection of Rectal Lesions With the ColubrisMX ELS System

Study Overview
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Brief Summary
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This study is a prospective, single-arm, multi-center, open-label, staged clinical study. Overall Objective: To evaluate the safety and effectiveness of the ELS System in subjects undergoing transanal endoluminal procedures in the rectum and distal colon (up to 17 cm from the anal verge). To validate a program for training surgeons and their teams to successfully use the ELS System.

Detailed Description
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Endoscopic Mucosal Resection (EMR) is the current standard treatment for non-malignant colorectal polyps in the United States. Large colorectal polyps are most often removed piecemeal when using EMR, as en-bloc resection becomes increasingly challenging with increasing lesion size. The major drawback of EMR is its low en-bloc resection rate. The piecemeal nature of the resection hinders margin assessment, which consequently results in low R0 resection rates and causes uncertainty regarding the appropriate treatment plan for the patient going forward. This outcome results in surveillance colonoscopies at shorter intervals to evaluate for recurrence, which in turn, increases patient anxiety and poses a burden on the healthcare system. Endoscopic Submucosal Dissection (ESD) enables en bloc resection and therefore improved histopathological assessment of margins and has been reported to have highly improved R0 resection rates when compared with EMR. ESD is a common treatment option for large colorectal lesions in Asia; however, the technical difficulty and steep learning curve, which are mainly attributed to the lack of traction and countertraction capability, have resulted in low adoption of ESD in the United States. The ColubrisMX Endoluminal Surgical (ELS) System represents a marked advancement in the removal of non-malignant colorectal lesions. Robotic-assisted instrumentation with bimanual dexterity allows for application of traction and counter-traction and closure of the defect via suturing, and enables the technically challenging, single-handed ESD procedure to be conducted via a two-handed, robotic-assisted, transanal endoluminal surgical approach. The ELS System consists of two main components: the Patient Cart and the Surgeon Console. This system gains access by means of a flexible overtube (Colubriscope) that can be manually inserted up to 17 cm into the distal colon. The ELS System provides full visualization of the surgical site and the ability to manipulate up to two surgical instruments and a robotic-assisted third-party flexible endoscope (Olympus GIF-XP190), which is referred to as the videoscope. The ELS Surgical Instruments are robotically assisted with full triangulation and articulation with up to 7 degrees of freedom to provide enhanced dexterity in narrow endoluminal anatomy.

Official Title
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Transanal Resection of Rectal Lesions With the ColubrisMX Endoluminal Surgical System (ELS System)

Conditions
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Rectal Adenoma, Rectal Polyp, Rectal Lesion

Intervention / Treatment
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* Device: ColubrisMX Endoluminal Surgical (ELS) System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 22-80 years BMI ≤ 40 kg/m2 ASA score ≤ 3 Subject agrees to participate in the study by giving signed informed consent Benign lesion that is located ≤ 17 cm from the anal verge, such as adenoma, submucosal nodule, or polyp Lesion size is ≤ 7 cm, with size determined according to the American College of Gastroenterology (ACGE) and the American College of Colon and Rectal Surgeons (ACCRS) guidelines as the dimension of the lesion that is greatest in extent. Exclusion Criteria: Preoperative: Anatomy unsuitable for endoscopic visualization or endoluminal surgery Prior radiation treatment for colorectal cancer Subject diagnosed with ≥ T1 colorectal cancer Subject with distant metastases Subject requiring Total Mesorectal Excision Untreated active infection Vulnerable population (e.g., prisoners, mentally disabled) Severe concomitant illness 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 subject is unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. Subjects with immunosuppression drugs (chemotherapy) due to an increased potential for infection and poor healing Subjects with a high cardiac or pulmonary risk (these subjects require clearance from a cardiologist and pulmonologist) Subjects on preoperative blood thinners, i.e., coumadin or heparin, that cannot be weaned prior to surgery History of inflammatory bowel disease Intraoperative: Existing stricture or anatomical blockage in lower GI tract preventing Colubriscope from reaching desired position. Inadequate bowel prep. Complex anatomical findings not feasible for endoluminal or partial thickness approach. Lesion demonstrates characteristics indicative of cancer, such as failure to lift upon submucosal injection, or any other features that raise the Investigator's suspicion of cancer. Confirmation that lesion is located further than the intended use of the ELS System (past 17 cm from the anal verge).

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Robotically assisted transanal endoluminal resection of rectal lesion<br> | Device: ColubrisMX Endoluminal Surgical (ELS) System<br>* Robotically assisted transanal endoluminal resection of rectal lesion using the ColubrisMX Endoluminal Surgical (ELS) System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| En Bloc Resection Rate (percent) | The En Bloc Resection Rate (percent) is defined as the percentage of target lesions that are excised in a single specimen. | Intraoperative | 
| R0 Resection Rate (percent) | The R0 Resection Rate (percent) is defined as the percentage of target lesions that have lateral and deep margins that are free of neoplasia under microscopic visualization. | 30 days | 
| Complication-Free Rate (percent) | The Complication-Free Rate (percent) is defined as the percentage of subjects free from complications graded as Clavien-Dindo ≥ III intraoperatively or postoperatively through Day 30. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion-Free Rate (percent) | The Conversion-Free Rate (%) is defined as the percentage of intended procedures that do not require conversion to another platform (e.g., TAMIS or TEM) or surgical modality (i.e., laparoscopic or open surgery) to achieve successful completion. | Intraoperative | 
| Adverse Events (percent) | Data on adverse events will be collected during and after surgery. Each adverse event will be evaluated to determine the severity, relationship to the investigational device, action taken with respect to the investigational device, outcome, etc. Adverse events will be classified as mild, moderate, severe, or life-threatening. | 30 days | 
| Readmission Rate (percent) | The Readmission Rate (percent) is defined as the percentage of subjects with readmission that can be linked to the resection procedure requiring an interventional procedure up to 30 days after surgery. | 30 days | 
| Reoperation Rate (percent) | The Reoperation Rate (percent) is defined as the percentage of subjects requiring reoperation that can be linked to the resection procedure up to 30 days after surgery. | 30 days | 
| Estimated Blood Loss (mL) | Estimated Blood Loss (mL) is the amount of intraoperative blood loss (up to the point of needing transfusion). Estimated Blood Loss will be categorized as Significant, if transfusion is required, or Not Significant, if transfusion is not required. | Intraoperative | 
| Subjects Requiring Transfusion (percent) | Subjects Requiring Transfusion (percent) is defined as the percentage of subjects requiring transfusion prior to discharge. | 30 days | 
| Length of Stay (days) | The Length of Stay (days) is the amount of days that the subject stays in the hospital related to the resection procedure. | 30 days | 
| Mortality (percent) | Mortality (percent) is the percentage of subjects with a mortality from any cause up to 30 days, regardless of whether it was device/procedure-related or not. | 30 days | 
| Fecal Incontinence (percent) | Fecal Incontinence (percent) is the percentage of subjects with clinically significant disturbance to fecal continence from preoperative baseline to postoperative Day 30. | 30 days | 
| Rate of Rectal Stricture/Stenosis (percent) | A proctoscopic exam will be performed to assess rectal stricture/stenosis at 30 days post-procedure. Incidence of rectal stricture/stenosis detected at or before this follow-up visit will be recorded. | 30 days | 
| Local Recurrence Rate (percent) (subjects with cancer diagnosis only) | In subjects with lesions upstaged to histologically confirmed cancerous lesions post-resection with the ELS System, local recurrence will be monitored via five-year follow-up according to NCCN rectal cancer guidelines. The rate of local recurrence (%) in these subjects will be recorded. | 5 years | 
| Disease Free Survival (percent) (subjects with cancer diagnosis only) | In subjects with lesions upstaged to histologically confirmed cancerous lesions post-resection with the ELS System, disease free survival will be monitored via five-year follow-up according to NCCN rectal cancer guidelines. The rate of disease-free survival (%) in these subjects will be recorded. | 5 years | 
| Overall Survival (percent) (subjects with cancer diagnosis only) | In subjects with lesions upstaged to histologically confirmed cancerous lesions post-resection with the ELS System, overall survival will be monitored via five-year follow-up according to NCCN rectal cancer guidelines. The rate of overall survival (%) in these subjects will be recorded. | 5 years | 
| Vital Signs | Vital signs will be collected at preoperative baseline and post operative Days 7 and 30. | 30 days | 
| Clinical Laboratory Assessments | Clinical laboratory parameters will be collected at preoperative baseline and at discharge. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal Adenoma, Rectal Polyp, Rectal Lesion, Endoscopic Submucosal Dissection, Robotic Surgery, Endoluminal Surgery, Transanal Minimally Invasive Surgery, Transanal Surgery, Resection