Chyme Reinfusion for Type 2 Intestinal Failure

Pivotal Study to Evaluate the Safety and Efficacy of the Insides™ System in the Treatment of Subjects With a Double Enterostomy and/or Enterocutaneous Fistula and Type 2 Intestinal Failure.

This project aims to introduce and evaluate a novel assistive prosthetic system that helps prevent and treat nutrient and fluid loss from enterocutaneous fistulas. The device system functions simply to return the output from a fistula back into the distal limb of the intestine.

The development of enterocutaneous fistulas are devastating consequences of surgery or surgical diseases. They cause excessive fluid and nutrient losses from the gut resulting in severe dehydration and intestinal failure mandating invasive medical therapies to improve survival. These disorders inflict a vast burden of suffering, morbidity, and mortality on patients, while extracting enormous per-patient resources from healthcare systems. Parenteral nutrition is often required, meaning prolonged hospital stay, an attendant risk of line sepsis, venous damage and thrombosis, liver impairment, and death.

There is a pressing demand for breakthrough technologies that can restore lost fluids and nutrients to the body in patients affected by enterocutaneous fistulas in order to reverse intestinal failure, eliminate the need for parenteral nutrition, prevent dehydration and renal injury, allow safe care in the community, enable chemotherapy completion, and restore quality of life.

Inclusion Criteria:

• Age ≥ 21 years
• Able to provide written informed consent
• Dependent on parenteral nutrition (PN)
• DES/ECF with exposed afferent and efferent limbs visible on the abdominal wall
• Minimum of 2 weeks post DES/ECF creation
• Distal limb of DES/ECF opening can be intubated by a minimum 24Fr feeding tube (dilatation of orifice strictures is allowable)

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