ColoSeal™ ICD System Safety and Feasibility Studies

Prior treatment

• Major surgical or interventional procedures within 30 days prior to this study or planned major surgical or interventional procedures within 1 month of entry into this study
• Patient has received systemic chemotherapy or radiation to the pelvis within 30 days prior to the planned procedure
• 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
• Subject has undergone a prior pelvic anastomosis
• Inadequate bowel preparation prior to the procedure
• Known allergy to iodine or iodine-based contrast unless subject can be adequately premedicated prior to leak test
• Subject has unresolved alcohol abuse or illegal drug use
• Subject is pregnant or planning to become pregnant. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to surgical procedure
• Subject is currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints

Other illness

• Subject has local or systemic infection at the time of intervention.
• Subject has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, ischemic bowel, carcinomatosis, diverticulitis, or extensively spread inflammatory bowel disease
• Known allergy to any component of the device
• Any condition or abnormality which in the opinion of the investigator may jeopardize the subject's safe participation or the quality of the data

Lab values

• Albumin \< 30 g/liter

Other

• Subject with a life expectancy \< 1 year
• Subjects with ASA classification \> 3
• Subject has an anatomic abnormality (e.g., polyp, diverticula, vascular malformation) or bowel damage at or within 5 cm of the target device anchor site that could interfere with safe device function
• Subjects has a diagnosis of coagulopathy, thrombocytopenia, immune suppression
• BMI ≥ 40
• Subjects is taking antimetabolites or antiplatelet agents (with the exception of aspirin)
• Subject requires an end-to-end anastomosis smaller than 31 mm in diameter
• Anastomotic leak detected during intraoperative leak testing
• Subject is unable or unwilling to provide informed consent

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