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

Last updated: October 3, 2025
Sponsor: Eclipse Regenesis, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ileus

Bowel Dysfunction

Treatment

Distraction Enterogenesis in Adult Patients with Short Bowel Syndrome

Clinical Study ID

NCT05535361
CLIN-0001
R44DK127658
  • Ages 3-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject has short bowel syndrome, defined as 50% or less of expected bowel lengthbased on subject age and/or height, and measured at the time of the subject's priorintestinal 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 therequirements of the study and is willing to bring the subject to all clinic visitsand complete all study related procedures (as determined by the investigator).

Exclusion

Exclusion Criteria:

  • Ultra-short bowel syndrome defined as less than 3 cm of bowel length.

  • Diagnosed Inflammatory bowel disease-unclassified (not Crohn's or ulcerativecolitis)

  • 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 haveundergone organ transplantation, chemotherapy or radiotherapy within the past 12months, who have clinically significant leukopenia, who are positive for the humanimmunodeficiency virus (HIV) or whose immune status makes the subject a poorcandidate for clinical trial participation in the opinion of the Investigator.

  • Subject is determined by the investigator to be unsuitable for participation in thistrial for any reason.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Distraction Enterogenesis in Adult Patients with Short Bowel Syndrome
Phase:
Study Start date:
September 15, 2025
Estimated Completion Date:
June 30, 2028

Study Description

This clinical investigation is a study to evaluate safety and probable benefit of the Eclipse XL1 System in pediatric and adult subjects with short bowel syndrome. This study is a single arm study and will enroll subjects ages 3 months to 65 years old at up to 10 study sites in the United States. This study will be open label; treatment allocation will be known by the subjects, the Principal Investigator and his medical staff. Recruitment is expected to occur over the course of 24-36 months.

Device placement will be administered during a standalone procedure or a previously planned procedure that is otherwise needed by the study subject. Subjects may receive up to 2 devices at one time and/or have multiple procedures over time based on clinical necessity Study objectives will be monitored by reviewing patient nutrition, weight, and stool assessment data. The study device will also monitored by radiographic examination to confirm location of the device and assess the safety and probable benefit of distraction enterogenesis until the device is removed or passes out of the intestine naturally. Patients will be followed while the study device is in situ and at 3 and 6 months post device passing or removal. Subjects may or may not be discharged from the hospital while participating in the study, and investigators may recommend that a subject stay in-patient for a portion or the entire length of study, depending on subject health.

Connect with a study center

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • Stanford University School of Medicine

    Stanford, California 94304
    United States

    Site Not Available

  • Lucile Packard Children's Hospital Stanford

    Palo Alto 5380748, California 5332921 94303
    United States

    Active - Recruiting

  • University of California San Francisco

    San Francisco 5391959, California 5332921 94143
    United States

    Active - Recruiting

  • Stanford University School of Medicine

    Stanford 5398563, California 5332921 94304
    United States

    Active - Recruiting

  • Children's National Hospital

    Washington D.C. 4140963, District of Columbia 4138106 20010
    United States

    Active - Recruiting

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Active - Recruiting

  • Cincinnati Children's Hospital

    Cincinnati, Ohio 45229-3026
    United States

    Site Not Available

  • Cincinnati Children's Hospital

    Cincinnati 4508722, Ohio 5165418 45229-3026
    United States

    Active - Recruiting

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