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 22, 2024
Sponsor: Eclipse Regenesis, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bowel Dysfunction

Treatment

Distraction Enterogenesis in Adult Patients with Short Bowel Syndrome

Clinical Study ID

NCT05535361
CLIN-0001
R44DK127658
  • Ages 12-65
  • 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 10 cm.

  • Male or female patients aged 12 months to 65 years inclusive

  • Subject has scheduled open abdominal procedure for different indication than studydevice (i.e., ostomy take-down, stoma-take-down, open liver biopsy, and proceduresto correct the following: bowel obstruction, strictures, adhesions).

  • 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:

  • Previously performed intestinal resection and/or bowel lengthening procedure < 6months from screening visit.

  • Ultra-short bowel syndrome defined as less than 10 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: 15
Treatment Group(s): 1
Primary Treatment: Distraction Enterogenesis in Adult Patients with Short Bowel Syndrome
Phase:
Study Start date:
January 15, 2023
Estimated Completion Date:
June 30, 2026

Study Description

The first phase of the study shall consisted of 5 subjects (aged 18 to 50 years) with an FDA review after 3 subjects with defunctional and functional limbs. Phase 1 initial adult subjects were enrolled and assessed in order to demonstrate an acceptable safety profile. FDA approval was received to advance to subsequent phases of the study.

This next phase (Phase 2) consists of 10 subjects (aged 12 months to 65 years) at 6 centers in the United States.

Device placement will be administered during a previously planned procedure that is otherwise needed by the study subject. Study assessments for the objectives will be collected by radiographic examination to determine length of intestinal lengthening and assessment of safety and clinical improvement until the device is removed or passes out of the intestine naturally. The surgeon shall also review ultrasounds and complete blood counts daily for 7 days post-operatively and weekly post-7 days until device passage or removal to assess for intussusception or infection. Follow up will continue 30 days after the device is removed or naturally passed by the subject. 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 the entire length of study, depending on subject health

Connect with a study center

  • Stanford University School of Medicine

    Stanford, California 94304
    United States

    Active - Recruiting

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