ColoSeal™ ICD System Anastomotic Protection Pivotal Study

Exclusion Criteria

• •Preoperative:
• •1. Subject at the time of baseline screening is not planned to have ostomy reversal prior to 6 months post-index procedure.
• •2. Subject with a life expectancy \< 1 year due to condition other than rectal cancer.
• •3. Subject with American Society of Anesthesiologists (ASA) classification \> 3.
• •4. Subject has a systemic infection at the time of surgery or requiring systemic antimicrobial therapy up to 1 week before surgery.
• •5. Subject had major surgical or interventional procedure within 30 days before the index procedure or planned major surgical or interventional procedure within 30 days after the index procedure.
• •6. Subject has received systemic chemotherapy or radiation to the pelvis within 30 days before the planned procedure.
• •7. Subject has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, ischemic bowel, carcinomatosis, diffuse descending colon diverticulosis (i.e., diverticula at potential planned fixation site), diverticulitis, or inflammatory bowel disease in the descending colon.
• •8. 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.
• •9. Subject has a diagnosis of coagulopathy (INR≥1.5), thrombocytopenia (platelet count \<150,000/μL), or immune suppression (CD4+ T-cell count \<500 cells/mm³).
• •10. Subject has a condition resulting in significant cognitive impairment and/or functional decline, such as dementia or advanced Parkinsons disease.
• •11. Subject has a BMI ≥ 40.
• •12. Subject is scheduled for a concurrent major surgical procedure during the index procedure (e.g., liver resection).
• •13. Subject has been taking regular systemic steroid medication in the last 6 months prior to the index procedure.
• •14. Subject is taking anticoagulants, antimetabolites or antiplatelet agents (Note: low-dose aspirin therapy is permitted) within 7 days of the index procedure.
• •15. Subject has undergone a prior pelvic anastomosis.
• •16. Subject has fecal incontinence, involvement of the sphincter by neoplastic disease, or evidence of extensive local disease in the pelvis seen on pre-operative imaging.
• •17. Subject is diabetic with hemoglobin A1c \> 8.0% (64 mmol/mol).
• •18. Serum albumin of \< 3.0 g/dL.
• •19. Serum prealbumin of \<15mg/dL.
• •20. Subject has a known allergy to any component of the device.
• •21. Subject has a known allergy to iodine or iodine-based contrast unless the subject can be adequately premedicated before the leak test.
• •22. Subject has unresolved alcohol or drug abuse, in the investigator's opinion.
• •23. Subject is pregnant or planning to become pregnant (female subjects of childbearing potential must have a negative urinary pregnancy test ≤ 7 days before the surgical procedure).
• •24. Subject is unable or unwilling to provide informed consent.
• •25. Subject is currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints.
• •Intraoperative:
• •26. Subject is not planned to receive an ostomy placement at the time of the index procedure.
• •27. Subject's left colon (bowel) preparation on the day of surgery is deemed inadequate for ICD Device placement, as determined by the investigator.
• •28. Subject requires an end-to-end or side-to-end anastomosis smaller than 31 mm in diameter or greater than 10cm from the anal verge.
• •29. Subject failed intraoperative leak test.
• •30. Subject has any condition or abnormality which, in the opinion of the investigator, may jeopardize subject safety or the quality of the study data.