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New device aims to solve feeding problems in ICU patients with organ failure

NCT ID NCT05710315

Symptom relief Sponsor: Inova Health Care Services Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Updated 2 times

Summary

This study tests whether a device called RELiZORB™ can help critically ill adults with multiple organ failure better tolerate tube feedings. The device breaks down fats in the feeding to make them easier to digest. Researchers will compare how well patients meet their nutrition goals over five days with or without the device.

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

About 32 people

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

Started

May 2025

Expected to finish

Aug 2026

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.

Ages

18 to 89 years

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: * Male or female patients aged 18 - 89 years of age. * Patients who have Multi-Organ Failure (MOF) (defined as requiring mechanical ventilation and demonstrating at least one more system failure on the SOFA score on the day of ICU admission). * Patients who have not yet been initiated on enteral nutrition, yet enteral nutritional support is needed, or patients who have been initiated on enteral nutrition within the previous 48 hours. Enteral nutrition support defined as support planned to be given via any route connected to the gastrointestinal system (i.e., the enteral route). This includes tube feeding using nasogastric, nasoduodenal, gastrostomy, jejunostomy tubes, or similar. * Patients who lack the capacity to consent for themselves may be included upon receiving consent from their legally authorized representatives. Exclusion Criteria: * Pregnant women and prisoners. * Hypotension is attributed to suspected or confirmed cardiogenic shock. * Evidence of unresolved intestinal obstruction, ischemia, bleeding, perforation, fistulas or tract discontinuity, or other contraindication for enteral nutrition. * Sepsis suspected or confirmed due to an abdominal source and enteral nutrition is contraindicated. * C. Difficile or other gastrointestinal infection that may manifest with diarrhea. * Use of pancreatic hormone stimulant or inhibitor (e.g. octreotide, pancreatic enzyme supplements) during or immediately prior to hospital admission. * Any other reason that the treating or investigator team considers to be a contraindication to enteral nutrition.

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Conditions

The condition(s) this trial relates to.

exocrine pancreatic insufficiency multiple organ dysfunction syndrome

As listed by the trial registrant

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

Exocrine pancreatic insufficiency Multi organ failure

Contacts and locations

Locations

  • Inova Fairfax Medical Campus

    Falls Church, Virginia, 22042, United States

More trials for these conditions

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