ColoSeal™ ICD System Safety and Feasibility Study

Inclusion Criteria:

• Subject is 18-65 years of age at screening, or subject is 66-70 years of age atscreening with up to one cardiovascular, metabolic or pulmonary comorbidity for whichmedication is prescribed.
• Subject is diagnosed with rectosigmoid or rectal cancer
• Subject is scheduled for elective resection, either open, laparoscopic or robotic withmesorectal excision (either abdominal or transanal approach) which will require thecreation of an anastomosis and protective ostomy (anastomosis maximally 15 cm from theanal verge).
• The subject has been informed of the nature of the study, agrees to its provisions andhas provided written informed consent, approved by the appropriate Medical EthicsCommittee (EC) or Institutional Review Board (IRB).
• Subject must be willing and able to comply with study follow-up requirements.

Exclusion Criteria:

• Subject with a life expectancy < 1 year
• Subjects with ASA classification > 3
• Albumin < 30 g/liter
• Subject has local or systemic infection at the time of intervention.
• Major surgical or interventional procedures within 30 days prior to this study orplanned major surgical or interventional procedures within 1 month of entry into thisstudy
• Patient has received systemic chemotherapy or radiation to the pelvis within 30 daysprior to the planned procedure
• Subject has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowelperforation, ischemic bowel, carcinomatosis, diverticulitis, or extensively spreadinflammatory bowel disease
• Subjects has a diagnosis of coagulopathy, thrombocytopenia, immune suppression
• BMI ≥ 40
• Subject is scheduled for a concurrent major surgical procedure during the surgery (e.g., liver resection)
• Subject has been taking regular systemic/ steroid medication in the last 3 months
• Subjects is taking antimetabolites or antiplatelet agents
• Subject has undergone a prior pelvic anastomosis
• Subject requires an end-to-end anastomosis smaller than 31 mm in diameter
• Known allergy to any component of the device
• Known allergy to iodine or iodine-based contrast
• Any condition or abnormality which in the opinion of the investigator may jeopardizethe subject's safe participation or the quality of the data
• Subject is pregnant or planning to become pregnant. Female subjects of child-bearingpotential must have a negative pregnancy test done within 7 days prior to surgicalprocedure
• Subject is unable or unwilling to provide informed consent
• Subject is currently participating in an investigational drug or another device studythat clinically interferes with the current study endpoints