Chyme Reinfusion for Type 2 Intestinal Failure (REINFUSE)
Intestinal Failure, Enterocutaneous Fistula, Ileostomy - Stoma
About this trial
This is an interventional treatment trial for Intestinal Failure focused on measuring Chyme reinfusion, Intestinal failure, TPN or PN, Parenteral nutrition, Enterocutaneous fistula, Effluent, Ileostomy - stoma
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
Sites / Locations
- Shands Hospital
- University Miami Hospital and Clinics
- University IllinoisRecruiting
- Massachusetts General Medical Center
- Henry Ford Medical CenterRecruiting
- University NebraskaRecruiting
- Addenbrooke's Hospital
- St James HospitalRecruiting
- St Marks HospitalRecruiting
- Nottingham University HospitalRecruiting
- University Hospital SouthamptonRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Active
Control
Reinfusion of chyme using the Insides System for subjects with Type II intestinal failure dependent on PN
Standard of care therapies in accordance with ASPEN and ESPEN treatment guidelines