Safety Study of SIC 8000 in Subjects Undergoing Endoscopic Mucosal Resection (EMR) of Colonic Lesions Equal to or Larger Than 2 cm

Exclusion Criteria

• •1. Age: Subjects under 18 years old are excluded
• •2. Consent: Subjects who refuse or who are unable to consent, vulnerable subjects are excluded.
• •3. Pregnancy: Pregnant or breastfeeding women
• •4. ASA status: High anesthetic risk (ASA score \> 3)
• •5. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
• •6. Study participation: Subjects currently enrolled in any other clinical study or previous enrollment in a clinical study in the last 30 days
• •7. Subjects with Lesions less than 20 mm in largest dimension
• •8. Subjects with Lesions involving the muscularis propria (T2 lesions) on other staging modalities such as endoscopic ultrasonography (EUS)
• •9. Subjects with ulcerated depressed lesions (Paris type III) or biopsy proven invasive carcinoma
• •10. Presence of other malignant disease locally advanced or with metastasis
• •11. Presence of other lesions of the digestive tract as active Inflammatory colonic conditions (inflammatory bowel disease , e.g ulcerative colitis, Crohn's disease)
• •12. Endoscopic appearance of invasive malignancy
• •14. Previous partial resection or attempted resection of the target lesion is exclusionary.
• •15. Allergy: ascertained or presumptive hypersensitivity to study products; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study.
• •16. known or suspected gastrointestinal obstruction or perforation, toxic megacolon, active diverticulitis.
• •17. inflammatory bowel disease e.g ulcerative colitis or Crohn's 's disease
• •18. Hemostasis disorders (eg Von Willebran disease, haemophilia or factor V Leiden thrombophilia), known clotting disorder (INR\>1.5 that cannot be corrected).
• •19. Other medical condition that in the investigator's opinion would make the administration of the study IMD or procedures hazardous to the subject.
• •20. Medical treatments (i.e.: radiotherapy, surgical endoscopic treatments) before the intervention.