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.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Intestinal Failure
- Sponsor
- The Insides Company
- Enrollment
- 44
- Locations
- 11
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief 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.
Detailed Description
The development of enterocutaneous fistulas are devastating consequences of surgery or surgical diseases. They cause excessive fluid and nutrient losses from the gut resulting in severe dehydration and intestinal failure mandating invasive medical therapies to improve survival. These disorders inflict a vast burden of suffering, morbidity, and mortality on patients, while extracting enormous per-patient resources from healthcare systems. Parenteral nutrition is often required, meaning prolonged hospital stay, an attendant risk of line sepsis, venous damage and thrombosis, liver impairment, and death. There is a pressing demand for breakthrough technologies that can restore lost fluids and nutrients to the body in patients affected by enterocutaneous fistulas in order to reverse intestinal failure, eliminate the need for parenteral nutrition, prevent dehydration and renal injury, allow safe care in the community, enable chemotherapy completion, and restore quality of life.
Investigators
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)
Outcomes
Primary Outcomes
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.
Time Frame: 30 days post randomization
Between group comparison of the proportion of subjects who achieve a 50% reduction in the use of parenteral nutrition
Secondary Outcomes
- Efficacy - Between group comparison of the time to reduction in the use of PN(30 and 60 days)
- Efficacy - Between group comparison of the time to discontinuation in the use of PN(30 and 60 days)
- Efficacy - Between group comparison of the time to reduction in the use of other parentral support fluids(30 and 60 days)
- Safety - Between group comparison of the incidence of serious adverse events(30 and 60 days)
- Efficacy - Between group comparison of the time to ostomy closure(30 and 60 days)
- Safety - Between group comparison of medication use to control fluid loss due to high output enterostomies(30 and 60 days)
- Safety - Between group comparison of nutritional failure measured by the nutritional risk index (NRI)(30 and 60 days)
- Safety - Between group comparison of peristomal skin complications(30 and 60 days)
- Healthcare Utilization - Between group comparison of length of stay for index hospitalization(up to 30 days)
- Healthcare Utilization - Between group comparison of all cause hospitalizations(30 and 60 days)
- Healthcare Utilization - Between group comparison of hospitalizations due to dehydration(30 and 60 days)
- Device performance - The overall incidence of device related adverse effects(30 and 60 days)
- Quality of Life - Between group comparison of quality of life indices as measured by the EuroQol 5D(30 and 60 days)
- Quality of Life - Between group comparison of quality of life indices as measured by the Stoma QoL Questionnaire(30 and 60 days)
- Quality of Life - Between group comparison of quality of life indices as measured by the Beck Depression Inventory(30 and 60 days)