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New portable pump could let fistula patients ditch IV nutrition at home

NCT ID NCT06751628

Disease control Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a small, portable pump that collects digestive fluids lost through a fistula or stoma and returns them to the lower intestine. The goal is to reduce the need for IV nutrition and help patients manage their condition at home. The trial will enroll 100 adults with high-output fistulas or double enterostomies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
portable chyme reinfusion pump (Insides System device)
What this could lead to
If successful, this device could allow patients with high-output fistulas to manage their condition at home, reduce dependence on IV nutrition, and shorten hospital stays.
What could go wrong
This is a single-arm study with only 100 participants, so results may not apply to all patients. The device requires fine motor skills and cognitive ability, which may limit who can use 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.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Patients with HOF (High-Output Fistulas) who are candidates for chyme reinfusion (CR) using the Insides System device will be included in the study during the pre-implantation consultation or a follow-up consultation. Patient characteristics prior to CR, as well as data related to the objectives mentioned above, will be collected both before device implantation and up to three months after intestinal reconnection

Ages

18 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: High-output stoma or enterocutaneous fistula (\>1500 mL per day or \>1000 mL per day with impact on hydration and nutritional status) Double enterostomy or enterocutaneous fistula with an anatomical configuration allowing chyme reinfusion (CR) Confirmed patency of the downstream digestive segment through digestive contrast imaging Exclusion Criteria: Stricture or fistula in the downstream digestive segment Patient refusal to use the device Fine motor or cognitive impairments preventing the patient or a caregiver from handling the device

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Conditions

The condition(s) this trial relates to.

intestinal fistula

As listed by the trial registrant

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

Enterostomy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU de Nantes

    RECRUITING

    Nantes, Nantes, 44000, France

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