Chyme Reinfusion for Type 2 Intestinal Failure

Launched by THE INSIDES COMPANY · Sep 30, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new device designed to help people with intestinal failure, specifically those dealing with conditions like enterocutaneous fistulas or ileostomies. The device works by taking waste fluid from the body and returning it safely into the intestines, which may help prevent the loss of important nutrients and fluids. Researchers hope this innovative system can improve the quality of life for people who rely on parenteral nutrition (a method of feeding that bypasses the digestive system) and have visible openings on their abdomen due to these conditions.

To participate in this study, you must be at least 21 years old and able to give your consent. You should also be dependent on parenteral nutrition and have had your fistula created for at least two weeks. However, individuals with certain health issues, such as bowel obstructions or specific infections, won't be eligible. If you join this trial, you can expect to be closely monitored while using the device, and you’ll be contributing to important research that could help others in similar situations.

Gender

ALL

Eligibility criteria

• 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