Intestinal FailureREINFUSENCT04577456
Chyme Reinfusion for Type 2 Intestinal Failure
A study testing The Insides System in people with Intestinal Failure and Enterocutaneous Fistula, run by The Insides Company at 11 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Intestinal Failure, Enterocutaneous Fistula, Ileostomy - Stoma
- What is being tested?
- The Insides System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 15 Oct 2022to 18 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United Kingdom7 sites
Royal Devon and Exeter Hospital
Exeter, EX2 5DW
St James's Hospital
Leeds, LS9 7TF
St Mark's Hospital
London, NW107NS
Salford Royal Hospital
Manchester, M6 8HD
Royal Victoria Hospital
Newcastle upon Tyne, NE7 7DN
Nottingham University Hospital
Nottingham, NG5 1PB
University Hospital Southampton
Southampton, SO16 6YD
United States4 sites
University Illinois
Chicago, Illinois, 60607
Shands Hospital
Gainesville, Florida, 32611
University Nebraska
Lincoln, Nebraska, 68198
University Miami Hospital and Clinics
Miami, Florida, 33136
About this study
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.
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.
Read the 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.
- Being tested
- The Insides System
- Keywords
- Chyme reinfusion, Intestinal failure, TPN or PN, Parenteral nutrition, Enterocutaneous fistula, Effluent, Ileostomy - stoma, Refeeding
- Medical subject headings
- Intestinal Failure, Intestinal Fistula, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Insides SystemDevice
Novel pump designed to return effluent from the ostomy bag to the distal gut
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Reinfusion of chyme using the Insides System for subjects with Type II intestinal failure dependent on PN Receives: Device: The Insides System |
| Control | No intervention | Standard of care therapies in accordance with ASPEN and ESPEN treatment guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days post randomization
Secondary outcomes (15)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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
Measured: 30 and 60 days
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
Measured: up to 30 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 30 and 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start15 Oct 2022
- Primary completion17 Nov 2025
- Study completion18 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Global multi center prospective randomized controlled study
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Insides Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Databean, Green Lane Coordinating Centre Limited, BioValeo
- Responsible party
- Sponsor
- Investigators
- Dermot Burke, MD, Principal investigator, St. James Hospital, Leeds, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577456
- Sponsor's protocol ID
- TICL-001 G190281
- Acronym
- REINFUSE
- Status last verified
- Dec 2025
- First submitted
- 16 Sep 2020
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04577456
- Acronym / sponsor ID
- REINFUSE / TICL-001 G190281
- Keywords
- Chyme reinfusion, Intestinal failure, TPN or PN, Parenteral nutrition, Enterocutaneous fistula, Effluent, Ileostomy - stoma, Refeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- The Insides CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Databean, Green Lane Coordinating Centre Limited, BioValeo
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 17 Nov 2025 (actual)
- Study completion
- 18 Nov 2025 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Global multi center prospective randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Device: The Insides SystemReinfusion of chyme using the Insides System for subjects with Type II intestinal failure dependent on PN |
| Control | No intervention | –Standard of care therapies in accordance with ASPEN and ESPEN treatment guidelines |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Insides SystemNovel pump designed to return effluent from the ostomy bag to the distal gut | Device | Active |
Primary outcome
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.
Time frame: 30 days post randomization
Between group comparison of the proportion of subjects who achieve a 50% reduction in the use of parenteral nutrition
15 secondary outcomes
Efficacy - Between group comparison of the time to reduction in the use of PN
Time frame: 30 and 60 days
Efficacy - Between group comparison of the time to discontinuation in the use of PN
Time frame: 30 and 60 days
Efficacy - Between group comparison of the time to reduction in the use of other parentral support fluids
Time frame: 30 and 60 days
Safety - Between group comparison of the incidence of serious adverse events
Time frame: 30 and 60 days
Efficacy - Between group comparison of the time to ostomy closure
Time frame: 30 and 60 days
Safety - Between group comparison of medication use to control fluid loss due to high output enterostomies
Time frame: 30 and 60 days
Safety - Between group comparison of nutritional failure measured by the nutritional risk index (NRI)
Time frame: 30 and 60 days
Safety - Between group comparison of peristomal skin complications
Time frame: 30 and 60 days
Healthcare Utilization - Between group comparison of length of stay for index hospitalization
Time frame: up to 30 days
Healthcare Utilization - Between group comparison of all cause hospitalizations
Time frame: 30 and 60 days
Healthcare Utilization - Between group comparison of hospitalizations due to dehydration
Time frame: 30 and 60 days
Device performance - The overall incidence of device related adverse effects
Time frame: 30 and 60 days
Quality of Life - Between group comparison of quality of life indices as measured by the EuroQol 5D
Time frame: 30 and 60 days
Quality of Life - Between group comparison of quality of life indices as measured by the Stoma QoL Questionnaire
Time frame: 30 and 60 days
Quality of Life - Between group comparison of quality of life indices as measured by the Beck Depression Inventory
Time frame: 30 and 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dermot Burke, MD principal investigator
St. James Hospital, Leeds, UK
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Insides System in people with Intestinal Failure and Enterocutaneous Fistula, run by The Insides Company at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United Kingdom, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 30 days post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025; AzTrials last refreshed its copy on 29 Oct 2026.