Chyme Reinfusion for Type 2 Intestinal Failure
Completed · Not applicable
Conditions studied: Intestinal Failure, Enterocutaneous Fistula, Ileostomy - Stoma, High Output Stoma
In brief
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.
Key facts
- Study ID
- NCT04577456
- Run by
- The Insides Company
- People needed
- 44
- Starts
- 2022-10-15
- Expected to finish
- 2025-11-18
- Last updated by the study team
- 2025-12-08
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Shands Hospital — Gainesville, Florida, United States
- University Miami Hospital and Clinics — Miami, Florida, United States
- University Illinois — Chicago, Illinois, United States
- University Nebraska — Lincoln, Nebraska, United States
- Royal Devon and Exeter Hospital — Exeter, United Kingdom
- St James's Hospital — Leeds, United Kingdom
- St Mark's Hospital — London, United Kingdom
- Salford Royal Hospital — Manchester, United Kingdom
- Royal Victoria Hospital — Newcastle upon Tyne, United Kingdom
- Nottingham University Hospital — Nottingham, United Kingdom
- University Hospital Southampton — Southampton, United Kingdom
Full record on ClinicalTrials.gov
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