PARADIGM - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System

Eligibility Criteria

• 1. Subject is between the ages of 22 to 80 years at the time of consent.
• 2. Subject has a BMI ≤ 50 kg/m2.
• 3. Subject has an ASA score of ≤ 3.
• 4. Subject has benign lesion(s) of the rectum or sigmoid colon, such as adenoma (with low- or high-grade dysplasia), neuroendocrine tumor, or other type of polyp as assessed by the most recent colonoscopy/flexible sigmoidoscopy.
• 5. Subject has lesion ≤ 7 cm in size (dimension of greatest extent) and ≤ 75% of the colorectal circumference as assessed by the most recent colonoscopy/flexible sigmoidoscopy.
• 6. Subject is eligible for standard endoscopic submucosal dissection.
• 7. Subject agrees to participate in the study by giving signed informed consent.
• 1. Subject anatomy is unsuitable for endoscopic visualization or endoluminal surgery.
• 2. Subject has a history of inflammatory bowel disease.
• 3. Subject has an untreated active infection at the time of the procedure.
• 4. Subject is considered part of a vulnerable population (e.g., prisoners, mentally disabled).
• 5. Subject has a severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions (e.g., cancer).
• 6. Subject is breastfeeding or pregnant or intends to become pregnant during the study.
• 7. Subject is 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.
• 8. Subject with EF ≤ 45, high cardiac or high pulmonary risk (these subjects require clearance from a cardiologist and pulmonologist, as applicable).
• 9. Subject on preoperative blood thinners, such as coumadin or heparin, that cannot be weaned prior to surgery.
• 10. Subject is moderately or severely immunocompromised.
• 11. 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.
• 1. Inadequate bowel prep.
• 2. Complex anatomical findings not feasible for an endoluminal approach.
• 3. Anatomical narrowing distal to the lesion site.
• 4. Lesion not located in the rectum or sigmoid colon.
• 5. Lesion size \>7 cm (dimension of greatest extent) or occupies \>75% of the colorectal circumference.
• 6. Lesion demonstrates characteristics indicative of invasive carcinoma, such as failure to lift upon submucosal injection, or any other features that raise the Investigator's suspicion of cancer.
• 7. In the opinion of the Investigator, the subject and/or subject anatomy is not suitable for study device use for any reason.
• 8. Lesion location not accessible by the study device.