Chyme Reinfusion for Type 2 Intestinal Failure (REINFUSE)

The Insides Company

Status

Completed

Conditions

High Output Stoma

Ileostomy - Stoma

Intestinal Failure

Enterocutaneous Fistula

Treatments

Device: The Insides System

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT04577456

TICL-001 G190281

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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