Clinical trial NCT04577456: Chyme Reinfusion for Type 2 Intestinal Failure
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intestinal Failure
Enterocutaneous Fistula
Ileostomy - Stoma
High Output Stoma
Keywords: Chyme reinfusion
Intestinal failure
TPN or PN
Parenteral nutrition
Enterocutaneous fistula
Effluent
Ileostomy - stoma
Refeeding
Lead sponsor: The Insides Company
Sponsor class: INDUSTRY
Collaborators: name: Databean
name: Green Lane Coordinating Centre Limited
name: BioValeo
First posted: 2020-10-08
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Global multi center prospective randomized controlled study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: 30 days post randomization
Secondary outcomes:
measure: Efficacy - Between group comparison of the time to reduction in the use of PN
timeFrame: 30 and 60 days
measure: Efficacy - Between group comparison of the time to discontinuation in the use of PN
timeFrame: 30 and 60 days
measure: Efficacy - Between group comparison of the time to reduction in the use of other parentral support fluids
timeFrame: 30 and 60 days
measure: Safety - Between group comparison of the incidence of serious adverse events
timeFrame: 30 and 60 days
measure: Efficacy - Between group comparison of the time to ostomy closure
timeFrame: 30 and 60 days
measure: Safety - Between group comparison of medication use to control fluid loss due to high output enterostomies
timeFrame: 30 and 60 days
measure: Safety - Between group comparison of nutritional failure measured by the nutritional risk index (NRI)
timeFrame: 30 and 60 days
measure: Safety - Between group comparison of peristomal skin complications
timeFrame: 30 and 60 days
measure: Healthcare Utilization - Between group comparison of length of stay for index hospitalization
timeFrame: up to 30 days
measure: Healthcare Utilization - Between group comparison of all cause hospitalizations
timeFrame: 30 and 60 days
measure: Healthcare Utilization - Between group comparison of hospitalizations due to dehydration
timeFrame: 30 and 60 days
measure: Device performance - The overall incidence of device related adverse effects
timeFrame: 30 and 60 days
measure: Quality of Life - Between group comparison of quality of life indices as measured by the EuroQol 5D
timeFrame: 30 and 60 days
measure: Quality of Life - Between group comparison of quality of life indices as measured by the Stoma QoL Questionnaire
timeFrame: 30 and 60 days
measure: Quality of Life - Between group comparison of quality of life indices as measured by the Beck Depression Inventory
timeFrame: 30 and 60 days
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands Hospital
state: Florida
city: Miami
country: United States
facility: University Miami Hospital and Clinics
state: Florida
city: Chicago
country: United States
facility: University Illinois
state: Illinois
city: Lincoln
country: United States
facility: University Nebraska
state: Nebraska
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital
city: Leeds
country: United Kingdom
facility: St James Hospital
city: London
country: United Kingdom
facility: St Marks Hospital
city: Manchester
country: United Kingdom
facility: Salford Royal Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
Study officials:
affiliation: St. James Hospital, Leeds, UK
name: Dermot Burke, MD
role: PRINCIPAL_INVESTIGATOR
References: