Chyme Reinfusion for Type 2 Intestinal Failure (NCT04577456) | Clinical Trial Compass
CompletedNot Applicable
Chyme Reinfusion for Type 2 Intestinal Failure
United States, United Kingdom44 participantsStarted 2022-10-15
Plain-language summary
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.
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Willebran…
What they're measuring
1
Efficacy - the proportion of subjects who achieve a 50% reduction in total caloric intake obtained from parenteral nutrition measured at 30 days post randomization compared to baseline.