Efficacy and Safety of the CG-100 Intraluminal Bypass Device

Exclusion Criteria16

• Patient has local or systemic infection at the time of intervention (e.g., peritonitis)
• Major surgical or interventional procedures within 45 days prior to this study or planned surgical or interventional procedures within 6 months of entry into this study (not including, placement of port for chemotherapy or ureter stent insertion).
• Patients with ASA classification \> 3
• Albumin \< 30 g/liter
• Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease
• Patients has a diagnosis of coagulopathy, thrombocytopenia, immune suppression
• BMI ≥ 40
• Patient is going through another surgical procedure (other than ileostomy, adhesiolysis) during the surgery.
• The patient is currently participating in another investigational drug or device study unless pre-approved by the sponsor.
• Patient has been taking regular systemic/ steroid medication in the last 6 months.
• Patients is taking antimetabolites or antiplatelet agents.
• Patient has preexisting sphincter problems
• Patient has evidence of extensive local disease in the pelvis or has undergone a prior pelvic anastomosis.
• Patients with massive diverticulosis at the sigmoid/descending colon (viewed on preoperative CT)
• Any condition or abnormality which in the opinion of the investigator may jeopardize the patient's safe participation or the quality of the data
• Pregnant or nursing female patients. Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to surgical procedure per site standard test.