Chyme Reinfusion for Type 2 Intestinal Failure (REINFUSE)

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.

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.

Study Overview

• Status: Completed
• Conditions: Ileostomy - Stoma; Intestinal Failure; High Output Stoma; Enterocutaneous Fistula
• Intervention / Treatment: Device: The Insides System

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Exeter, United Kingdom, EX2 5DW
    • Royal Devon and Exeter Hospital
  • Leeds, United Kingdom, LS9 7TF
    • St James's Hospital
  • London, United Kingdom, NW107NS
    • St Mark's Hospital
  • Manchester, United Kingdom, M6 8HD
    • Salford Royal Hospital
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Royal Victoria Hospital
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham University Hospital
  • Southampton, United Kingdom, SO16 6YD
    • University Hospital Southampton
• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • Shands Hospital
    • Miami, Florida, United States, 33136
      • University Miami Hospital and Clinics
  • Illinois
    • Chicago, Illinois, United States, 60607
      • University Illinois
  • Nebraska
    • Lincoln, Nebraska, United States, 68198
      • University Nebraska

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active; Reinfusion of chyme using the Insides System for subjects with Type II intestinal failure dependent on PN	Device: The Insides System; Novel pump designed to return effluent from the ostomy bag to the distal gut
No Intervention: Control; Standard of care therapies in accordance with ASPEN and ESPEN treatment guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare Utilization - Between group comparison of length of stay for index hospitalization	Between group comparison of length of stay for index hospitalization measured from the day of randomization to discharge	up to 30 days
Efficacy - Between group comparison of the time to reduction in the use of PN	Between group comparison of the time to reduction of parenteral nutrition measured in days	30 and 60 days
Efficacy - Between group comparison of the time to discontinuation in the use of PN	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	Between group comparison of the time to reduction in the use of other parenteral support fluids	30 and 60 days
Safety - Between group comparison of the incidence of serious adverse events	Between group comparison of the incidence of serious adverse events such as dehydration, metabolic disarray, failure to complete prescribed chemotherapy, IV line complications, fistula complications, device related effects	30 and 60 days
Efficacy - Between group comparison of the time to ostomy closure	Between group comparison of the time to surgery for ostomy closure measured in days	30 and 60 days
Safety - Between group comparison of medication use to control fluid loss due to high output enterostomies	Between group comparison of the use of proton pump inhibitors, anti motility agents, histamine receptor antagonists, a2 receptor antagonists, and somatostatins.	30 and 60 days
Safety - Between group comparison of nutritional failure measured by the nutritional risk index (NRI)	Between group comparison of the nutritional risk index (NRI). Nutritional failure risk will be categorized as severe (NRI<83.5), moderate (NRI 83.5 - 97.5) and low (NRI>97.5).	30 and 60 days
Safety - Between group comparison of peristomal skin complications	Between group comparison of peristomal skin complications measured by the discoloration, erosion, tissue overgrowth (DET) score as mild, moderate or severe	30 and 60 days
Healthcare Utilization - Between group comparison of all cause hospitalizations	Between group comparison of all cause hospitalizations measured by the total number of discreet hospitalizations >24 hours in duration	30 and 60 days
Healthcare Utilization - Between group comparison of hospitalizations due to dehydration	Between group comparison of hospital admissions >24 hours duration where the primary reason for admission is dehydration	30 and 60 days
Device performance - The overall incidence of device related adverse effects	The overall incidence of device related adverse effects reported in subjects randomized to the device. Effects may include effluent cycling time, device wear, device failure.	30 and 60 days
Quality of Life - Between group comparison of quality of life indices as measured by the Stoma QoL Questionnaire	Stoma QoL - This questionnaire consists of 20 questions. An example of a question could be: "I worry that the pouch will loosen." All the questions must be answered on a 4-point scale. The options for answering each question are: Always; Sometimes; Rarely; Not at all	30 and 60 days
Quality of Life - Between group comparison of quality of life indices as measured by the Beck Depression Inventory	Beck Depression Inventory - a 21 question survey where each question has 4 possible answers scored 0-3. The total score is summed to give an overall level of depression 1-10____________________These ups and downs are considered normal 11-16___________________ Mild mood disturbance 17-20___________________Borderline clinical depression 21-30___________________Moderate depression 31-40___________________Severe depression over 40__________________Extreme depression	30 and 60 days
Quality of Life - Between group comparison of quality of life indices as measured by the EuroQol 5D	Between group comparison of quality of life as measured by the EQ-5D-3L - a survey of the following five health dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression, and a health thermometer where 0= the worst health you can imagine and 100= the best health you can imagine.	30 and 60 days

Collaborators and Investigators

• Sponsor: The Insides Company
• Collaborators: Databean; Green Lane Coordinating Centre Limited; BioValeo
• Investigators: Principal Investigator: Dermot Burke, MD, St. James Hospital, Leeds, UK

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2022
• Primary Completion (Actual): November 17, 2025
• Study Completion (Actual): November 18, 2025

Study Registration Dates

• First Submitted: September 16, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Parenteral nutrition; Refeeding; Intestinal failure; Enterocutaneous fistula; Chyme reinfusion; TPN or PN; Effluent; Ileostomy - stoma
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Signs and Symptoms, Digestive; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Digestive System Fistula; Fistula; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Intestinal Failure; Intestinal Fistula; Hyperphagia
• Other Study ID Numbers: TICL-001 G190281

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No