Chyme Reinfusion for Type 2 Intestinal Failure

Description

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.

Conditions

Intestinal Failure, Enterocutaneous Fistula, Ileostomy - Stoma, High Output Stoma

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Study Overview

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Study Details

Study overview

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.

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.

Chyme Reinfusion for Type 2 Intestinal Failure

Condition
Intestinal Failure
Intervention / Treatment

-

Contacts and Locations

Gainesville

Shands Hospital, Gainesville, Florida, United States, 32611

Miami

University Miami Hospital and Clinics, Miami, Florida, United States, 33136

Chicago

University Illinois, Chicago, Illinois, United States, 60607

Lincoln

University Nebraska, Lincoln, Nebraska, United States, 68198

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Databean,

Dermot Burke, MD, PRINCIPAL_INVESTIGATOR, St. James Hospital, Leeds, UK

Study Record Dates

2025-03