RECRUITING

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

Conditions

Short Bowel Syndrome intestinal failure Necrotizing enterocolitis short gut intestinal volvulus intestinal atresia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official 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

Quick Facts

Study Start:2025-09-15

Study Completion:2028-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05535361

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Months to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	* 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.

Inclusion Criteria

Exclusion 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).

* 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.

Contacts and Locations

Study Contact

Andre Bessette

CONTACT

(617)249-0955

andre@eclipseregenesis.com

Eric Bannon

CONTACT

(781)710-8243

ebannon@alvamed.com

Study Locations (Sites)

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94303

United States

University of California San Francisco

San Francisco, California, 94143

United States

Stanford University School of Medicine

Stanford, California, 94304

United States

Children's National Hospital

Washington D.C., District of Columbia, 20010

United States

Boston Children's Hospital

Boston, Massachusetts, 02115

United States

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229-3026

United States

Collaborators and Investigators

Sponsor: Eclipse Regenesis, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-15

Study Completion Date2028-06-30

Study Record Updates

Study Start Date2025-09-15

Study Completion Date2028-06-30

Terms related to this study

Keywords Provided by Researchers

short bowel syndrome
intestinal failure
Necrotizing enterocolitis
short gut
intestinal volvulus
intestinal atresia

Additional Relevant MeSH Terms

Short Bowel Syndrome