A Prospective Investigation of the ColubrisMX ELS System

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