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Feasibility Study of Eclipse XL1 System for Short Bowel Syndrome

This study is testing a new device called the Eclipse XL1 System for adults and children with Short Bowel Syndrome (SBS). SBS is a condition where you have less than half of the expected length of your small intestine. The Eclipse XL1 System is designed to help the intestine grow longer through a process called Distraction Enterogenesis. Doctors will place the device inside your intestine during a surgical procedure. The main goal of this study is to see how safe the device and procedure are, and if it shows a probable benefit. We are looking for 40 participants between 3 months and 65 years old who have at least 3 cm of residual bowel length. The study will measure device and procedure-related side effects over 4 to 6 months.

Study design
This is a single-arm study, meaning all participants will receive the Eclipse XL1 System. It is an open-label study, so you and your doctors will know you are receiving the device. Up to 40 participants will be enrolled across 10 study sites in the United States.
What's involved
You will undergo a surgical procedure to have the Eclipse XL1 System placed in your intestine. Your nutrition, weight, and stool will be monitored, and X-rays will be used to check the device's location.
Compensation
Not stated in the trial record.
Follow-up
You will be followed while the device is in your body, and then for 3 and 6 months after the device is removed or passes naturally.

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NCT05535361

A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in Adult and Pediatric Patients With Short Bowel Syndrome

Recruiting
NAAges 3–65InterventionalTreatment
Eclipse Regenesis, Inc.
~40 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Distraction Enterogenesis in Adult Patients with Short Bowel Syndrome

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Device and procedure related adverse events
Measured over 4 to 6 months

Conditions

Short Bowel Syndrome

Explore related trials

Intestinal AtresiaIntestinal FailureIntestinal VolvulusNecrotizing EnterocolitisShort Bowel Syndrome

Where it's being run

5 sites across 4 states
California2
District of Columbia1
Massachusetts1
Ohio1

Who to contact

Andre Bessette
[email protected]
(617)249-0955
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Device and procedure related adverse events4 to 6 months

    Incident rate of moderate or severe procedure and/or device related adverse events