COMPLETED

Chyme Reinfusion for Type 2 Intestinal Failure

Conditions

Intestinal Failure Enterocutaneous Fistula Ileostomy - Stoma High Output Stoma Chyme reinfusion TPN or PN Parenteral nutrition Effluent Refeeding

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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.

Quick Facts

Study Start:2022-10-15

Study Completion:2025-11-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04577456

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.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Dermot Burke, MD

PRINCIPAL_INVESTIGATOR

St. James Hospital, Leeds, UK

Study Locations (Sites)

Shands Hospital

Gainesville, Florida, 32611

United States

University Miami Hospital and Clinics

Miami, Florida, 33136

United States

University Illinois

Chicago, Illinois, 60607

United States

University Nebraska

Lincoln, Nebraska, 68198

United States

Collaborators and Investigators

Sponsor: The Insides Company

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-15

Study Completion Date2025-11-18

Study Record Updates

Study Start Date2022-10-15

Study Completion Date2025-11-18

Terms related to this study

Keywords Provided by Researchers

Chyme reinfusion
Intestinal failure
TPN or PN
Parenteral nutrition
Enterocutaneous fistula
Effluent
Ileostomy - stoma
Refeeding

Additional Relevant MeSH Terms

Intestinal Failure
Enterocutaneous Fistula
Ileostomy - Stoma
High Output Stoma