Chyme Reinfusion for Type 2 Intestinal Failure

NCT04577456 | Completed DMC FDA Device

• 1 other identifier: TICL-001 G190281
• Study Type: interventional
• Target: 44
• Locations: 2 countries
• Sites: 11

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Between group comparison of the proportion of subjects who achieve a 50% reduction in the use of parenteral nutrition

  30 days post randomization

Secondary Outcomes (15)

• Efficacy - Between group comparison of the time to reduction in the use of PN

  30 and 60 days

• Efficacy - Between group comparison of the time to discontinuation in the use of PN

  30 and 60 days

• Efficacy - Between group comparison of the time to reduction in the use of other parentral support fluids

  30 and 60 days

• Safety - Between group comparison of the incidence of serious adverse events

  30 and 60 days

• Efficacy - Between group comparison of the time to ostomy closure

  30 and 60 days

Study Arms (2)

Active

EXPERIMENTAL

Reinfusion of chyme using the Insides System for subjects with Type II intestinal failure dependent on PN

Device: The Insides System

Control

NO INTERVENTION

Standard of care therapies in accordance with ASPEN and ESPEN treatment guidelines

Interventions

The Insides System DEVICE

Novel pump designed to return effluent from the ostomy bag to the distal gut

Active

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Insides Company: lead
• Databean: collaborator
• Green Lane Coordinating Centre Limited: collaborator
• BioValeo: collaborator

Study Sites (11)

Shands Hospital

Gainesville, Florida, 32611, United States

Location

University Miami Hospital and Clinics

Miami, Florida, 33136, United States

Location

University Illinois

Chicago, Illinois, 60607, United States

Location

University Nebraska

Lincoln, Nebraska, 68198, United States

Location

Royal Devon and Exeter Hospital

Exeter, EX2 5DW, United Kingdom

Location

St James's Hospital

Leeds, LS9 7TF, United Kingdom

Location

St Mark's Hospital

London, NW107NS, United Kingdom

Location

Salford Royal Hospital

Manchester, M6 8HD, United Kingdom

Location

Royal Victoria Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Nottingham University Hospital

Nottingham, NG5 1PB, United Kingdom

Location

University Hospital Southampton

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Intestinal Failure; Intestinal Fistula; Hyperphagia

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Digestive System Fistula; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Study Officials

• Dermot Burke, MD

  St. James Hospital, Leeds, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Global multi center prospective randomized controlled study

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: October 8, 2020
• Study Start: October 15, 2022
• Primary Completion: November 17, 2025
• Study Completion: November 18, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); GB (7)