Chyme Reinfusion for Type 2 Intestinal Failure

Exclusion Criteria

• •Insufficient distal access channel (distal limb) for device insertion
• •Bowel obstruction proximal to the DES/ECF
• •Small bowel obstruction, anastomotic leak, or perforation distal to the DES/ECF (diagnostic procedure such as gastrografin test, fistulograms, or similar must be performed, if there is a distal anastomosis with integrity not previously evaluated, to ensure that the subject is eligible)
• •Scheduled for DES/ECF reversal within 4 weeks of enrolment date
• •Current infection with Clostridium difficile colitis
• •Current infection small intestinal bacterial overgrowth (SIBO)
• •Signs or symptoms of systemic infection
• •Pre-existing gastrointestinal motility disorders including slow transit constipation, outlet obstruction, fecal incontinence, and gastroparesis
• •Metabolic, neurogenic, or endocrine disorders known to cause colonic dysmotility, e.g., multiple sclerosis, Parkinson's disease, hypothyroidism
• •Known peritoneal metastatic disease prior to DES/ECF closure (acceptable if only discovered at time of closure)
• •Liver cirrhosis
• •Hereditary coagulopathy, e.g., von Willebrand disease
• •Severe chronic renal insufficiency prior to DES/ECF formation (eGFR\<30mL/min/1.73m2)
• •Active implantable medical devices such as neuromodulation and cardiac systems
• •Metal stents implanted within 20cm of expected use of the controller
• •Women who are pregnant or breastfeeding
• •Subjects participating in an interventional clinical study within 30 days prior to randomization