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New device aims to cut IV nutrition needs for intestinal failure patients

NCT ID NCT04577456

Disease control Sponsor: The Insides Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a device that collects waste from an opening in the belly and returns it to the lower intestine. The goal was to see if it could reduce the amount of IV nutrition needed by at least half. 44 adults with intestinal failure and a fistula or double stoma took part. The device is meant to help manage the condition, not cure it.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

44 people

The number who actually took part.

Started

Oct 2022

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic intestinal failure Hyperphagia Intestinal Failure intestinal fistula

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Enterocutaneous fistula High output stoma Ileostomy - stoma Intestinal failure

Contacts and locations

Locations

  • Nottingham University Hospital

    Nottingham, NG5 1PB, United Kingdom

  • Royal Devon and Exeter Hospital

    Exeter, EX2 5DW, United Kingdom

  • Royal Victoria Hospital

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Salford Royal Hospital

    Manchester, M6 8HD, United Kingdom

  • Shands Hospital

    Gainesville, Florida, 32611, United States

  • St James's Hospital

    Leeds, LS9 7TF, United Kingdom

  • St Mark's Hospital

    London, NW107NS, United Kingdom

  • University Hospital Southampton

    Southampton, SO16 6YD, United Kingdom

  • University Illinois

    Chicago, Illinois, 60607, United States

  • University Miami Hospital and Clinics

    Miami, Florida, 33136, United States

  • University Nebraska

    Lincoln, Nebraska, 68198, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.