Actively Recruiting

Phase Not Applicable
Age: 3Months - 65Years
All Genders
ID05535361

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

Led by Eclipse Regenesis, Inc. · Updated on 2025-10-08

40

Participants Needed

6

Research Sites

17 weeks

Total Duration

On this page

Sponsors

E

Eclipse Regenesis, Inc.

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and potential benefits of the Eclipse XL1 System in both children and adults with short bowel syndrome, a condition characterized by having 50% or less of the expected bowel length. This study includes participants aged 3 months to 65 years and is conducted at multiple sites in the United States. The goal is to assess how the device may help with intestinal lengthening and nutritional status. Participants will receive the Eclipse XL1 device, which is placed inside the intestine during a standalone or planned surgical procedure. The device may be inserted once or multiple times depending on medical need, and the location is secured and marked for radiographic monitoring. The study is open label, meaning both participants and doctors know the treatment being given. During the study, participants are monitored while the device is inside their body and again at 3 and 6 months after the device is removed or naturally passes. Researchers will collect data on nutrition, weight, stool, and device position through x-rays. Safety is closely observed by tracking any device or procedure-related adverse events. The total follow-up includes up to 6 months after device removal or passage.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 3Months - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient has short bowel syndrome with 50% or less of expected bowel length for their age or height
  • Minimum residual bowel length of 3 cm
  • Age between 3 months and 65 years inclusive
  • Ability of the patient or legal guardian to read, understand, and provide informed consent
  • Willingness and ability to attend all clinic visits and complete study procedures as required
Not Eligible

You will not qualify if you...

  • Bowel length less than 3 cm (ultra-short bowel syndrome)
  • Diagnosed unclassified inflammatory bowel disease (not Crohn's or ulcerative colitis)
  • Active or prior Crohn's disease
  • Primary intestinal failure without resection of intestinal tissue
  • Coagulopathy with INR greater than 1.4 or platelets less than 100
  • Known immunocompromised status such as recent organ transplant, chemotherapy, radiotherapy, significant leukopenia, or HIV positive
  • Investigator decision deeming patient unsuitable for trial participation

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Single procedure

Participants undergo a standalone or planned procedure to have up to 2 Eclipse XL1 devices placed in their intestines for treatment of short bowel syndrome. The device placement is secured surgically and marked for radiologic evaluation.

1 procedure visit (in-person)

Monitoring

Duration - Up to 6 months or until device removal or natural passage

Participants are monitored while the study device remains in the intestine through patient nutrition, weight, stool assessments, and radiographic examinations to confirm device location and assess safety and benefit.

Regular assessments during device in situ (visit frequency determined by clinical need)

Follow-up

Duration - Up to 6 months post device removal or passage

Participants are followed after the device is removed or passes naturally to assess long-term safety and probable benefits, including intestinal lengthening and nutritional status.

2 visits (at 3 and 6 months post device removal or passage)

Trial Site Locations

Total: 6 locations

1

Lucile Packard Children's Hospital Stanford

Palo Alto, California, United States, 94303

Actively Recruiting

2

University of California San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

3

Stanford University School of Medicine

Stanford, California, United States, 94304

Actively Recruiting

4

Children's National Hospital

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

Actively Recruiting

5

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

6

Cincinnati Children's Hospital

Cincinnati, Ohio, United States, 45229-3026

Actively Recruiting

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Research Team

A

Andre Bessette

E

Eric Bannon

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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