Chyme Reinfusion for Type 2 Intestinal Failure
- Conditions
- Intestinal FailureEnterocutaneous FistulaIleostomy - StomaHigh Output Stoma
- Interventions
- Device: The Insides System
- Registration Number
- NCT04577456
- Lead Sponsor
- The Insides Company
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active The Insides System Reinfusion of chyme using the Insides System for subjects with Type II intestinal failure dependent on PN
- Primary Outcome Measures
Name Time Method 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. 30 days post randomization Between group comparison of the proportion of subjects who achieve a 50% reduction in the use of parenteral nutrition
- Secondary Outcome Measures
Name Time Method Efficacy - Between group comparison of the time to reduction in the use of PN 30 and 60 days Between group comparison of the time to reduction of parenteral nutrition measured in days
Efficacy - Between group comparison of the time to discontinuation in the use of PN 30 and 60 days Between group comparison of the time to discontinuation in the use of PN
Efficacy - Between group comparison of the time to reduction in the use of other parentral support fluids 30 and 60 days Between group comparison of the time to reduction in the use of other parenteral support fluids
Safety - Between group comparison of the incidence of serious adverse events 30 and 60 days Between group comparison of the incidence of serious adverse events such as dehydration, metabolic disarray, failure to complete prescribed chemotherapy, IV line complications, fistula complications, device related effects
Safety - Between group comparison of medication use to control fluid loss due to high output enterostomies 30 and 60 days Between group comparison of the use of proton pump inhibitors, anti motility agents, histamine receptor antagonists, a2 receptor antagonists, and somatostatins.
Healthcare Utilization - Between group comparison of all cause hospitalizations 30 and 60 days Between group comparison of all cause hospitalizations measured by the total number of discreet hospitalizations \>24 hours in duration
Device performance - The overall incidence of device related adverse effects 30 and 60 days The overall incidence of device related adverse effects reported in subjects randomized to the device. Effects may include effluent cycling time, device wear, device failure.
Quality of Life - Between group comparison of quality of life indices as measured by the Stoma QoL Questionnaire 30 and 60 days Stoma QoL - This questionnaire consists of 20 questions. An example of a question could be: "I worry that the pouch will loosen." All the questions must be answered on a 4-point scale. The options for answering each question are:
1. Always
2. Sometimes
3. Rarely
4. Not at allQuality of Life - Between group comparison of quality of life indices as measured by the Beck Depression Inventory 30 and 60 days Beck Depression Inventory - a 21 question survey where each question has 4 possible answers scored 0-3. The total score is summed to give an overall level of depression
1-10____________________These ups and downs are considered normal 11-16___________________ Mild mood disturbance 17-20___________________Borderline clinical depression 21-30___________________Moderate depression 31-40___________________Severe depression over 40__________________Extreme depressionSafety - Between group comparison of nutritional failure measured by the nutritional risk index (NRI) 30 and 60 days Between group comparison of the nutritional risk index (NRI). Nutritional failure risk will be categorized as severe (NRI\<83.5), moderate (NRI 83.5 - 97.5) and low (NRI\>97.5).
Healthcare Utilization - Between group comparison of length of stay for index hospitalization up to 30 days Between group comparison of length of stay for index hospitalization measured from the day of randomization to discharge
Healthcare Utilization - Between group comparison of hospitalizations due to dehydration 30 and 60 days Between group comparison of hospital admissions \>24 hours duration where the primary reason for admission is dehydration
Quality of Life - Between group comparison of quality of life indices as measured by the EuroQol 5D 30 and 60 days Between group comparison of quality of life as measured by the EQ-5D-3L - a survey of the following five health dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression, and a health thermometer where 0= the worst health you can imagine and 100= the best health you can imagine.
Safety - Between group comparison of peristomal skin complications 30 and 60 days Between group comparison of peristomal skin complications measured by the discoloration, erosion, tissue overgrowth (DET) score as mild, moderate or severe
Efficacy - Between group comparison of the time to ostomy closure 30 and 60 days Between group comparison of the time to surgery for ostomy closure measured in days
Trial Locations
- Locations (10)
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 Hospital
🇬🇧Leeds, United Kingdom
St Marks Hospital
🇬🇧London, United Kingdom
Salford Royal Hospital
🇬🇧Manchester, United Kingdom
Nottingham University Hospital
🇬🇧Nottingham, United Kingdom
University Hospital Southampton
🇬🇧Southampton, United Kingdom