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New device aims to grow gut length for short bowel patients

NCT ID NCT05535361

Disease control Sponsor: Eclipse Regenesis, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 13, 2026 · Updated 2 times

Summary

This study tests a device called the Eclipse XL1 that is placed inside the body to slowly stretch and lengthen the remaining small intestine in people with short bowel syndrome. The goal is to improve nutrition and reduce the need for intravenous feeding. The study will enroll 40 children and adults aged 3 months to 65 years who have at least 3 cm of bowel left. Researchers will monitor safety and measure how much the intestine grows.

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 40 people

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

Started

Sep 2023

Expected to finish

Jun 2028

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

3 months to 65 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: * Subject has short bowel syndrome, defined as 50% or less of expected bowel length based on subject age and/or height, and measured at the time of the subject's prior intestinal resection. * Minimum residual bowel length of 3 cm. * Male or female patients aged 3 mo to 65 years inclusive * The subject, parent or legal guardian of the subject is able to read, understand, and is willing to provide informed consent. * The subject or parent or legal guardian of the patient is able to understand the requirements of the study and is willing to bring the subject to all clinic visits and complete all study related procedures (as determined by the investigator). Exclusion Criteria: * Ultra-short bowel syndrome defined as less than 3 cm of bowel length. * Diagnosed Inflammatory bowel disease-unclassified (not Crohn's or ulcerative colitis) * Evidence of active or prior Crohn's disease. * Primary intestinal failure (i.e., without loss or resection of intestinal tissue). * Coagulopathy, as defined by INR \> 1.4 or platelets \< 100. * Known immunocompromised status including, but not limited to, individuals who have undergone organ transplantation, chemotherapy or radiotherapy within the past 12 months, who have clinically significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the subject a poor candidate for clinical trial participation in the opinion of the Investigator. * Subject is determined by the investigator to be unsuitable for participation in this trial for any reason.

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Conditions

The condition(s) this trial relates to.

intestinal atresia Intestinal Failure intestinal volvulus necrotizing enterocolitis short bowel syndrome

As listed by the trial registrant

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

Short bowel syndrome

How to take part

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

  1. The places running it

    5 sites. 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

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Children's National Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Cincinnati Children's Hospital

    RECRUITING

    Cincinnati, Ohio, 45229-3026, United States

  • Lucile Packard Children's Hospital Stanford

    RECRUITING

    Palo Alto, California, 94303, United States

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

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