Chyme reinfusion to treat 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 study is testing a new device that helps people with enterocutaneous fistulas by returning lost fluids and nutrients to their intestines to see if it can reduce their need for intravenous feeding and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | The Insides Company Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 10 sites (Gainesville, Florida and 9 other locations) |
| Trial ID | NCT04577456 on ClinicalTrials.gov |
What this trial studies
This project introduces a novel assistive prosthetic system designed to prevent and treat nutrient and fluid loss from enterocutaneous fistulas. The system works by returning the output from a fistula back into the distal limb of the intestine, addressing the severe dehydration and intestinal failure that can result from these conditions. By restoring lost fluids and nutrients, the intervention aims to eliminate the need for parenteral nutrition and improve the quality of life for affected patients. The study evaluates the effectiveness of this device in patients who are dependent on parenteral nutrition due to enterocutaneous fistulas.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 21 and older who are dependent on parenteral nutrition due to enterocutaneous fistulas.
Not a fit: Patients with insufficient distal access for device insertion or those scheduled for reversal of their enterocutaneous fistula within four weeks may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of intestinal failure and enhance the quality of life for patients with enterocutaneous fistulas.
How similar studies have performed: While the approach is innovative, similar studies exploring the management of enterocutaneous fistulas have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gainesville, Florida and 9 other locations
- Shands Hospital — Gainesville, Florida, United States (Recruiting)
- University Miami Hospital and Clinics — Miami, Florida, United States (Recruiting)
- University Illinois — Chicago, Illinois, United States (Completed)
- University Nebraska — Lincoln, Nebraska, United States (Recruiting)
- Royal Devon and Exeter Hospital — Exeter, United Kingdom (Recruiting)
- St James Hospital — Leeds, United Kingdom (Recruiting)
- St Marks Hospital — London, United Kingdom (Recruiting)
- Salford Royal Hospital — Manchester, United Kingdom (Recruiting)
- Nottingham University Hospital — Nottingham, United Kingdom (Recruiting)
- University Hospital Southampton — Southampton, United Kingdom (Completed)
Study contacts
- Principal investigator: Dermot Burke, MD — St. James Hospital, Leeds, UK
- Study coordinator: John Davidson, PhD
- Email: john@insidescompany.com
- Phone: +6498879309
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.