Evaluating the Eclipse XL1 System for treating Short Bowel Syndrome

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

This study is testing a new device called the Eclipse XL1 System to see if it can help improve intestinal function in adults and children with Short Bowel Syndrome.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 3 Months to 65 Years
• Sex: All
• Sponsor: Eclipse Regenesis, Inc. (other)
• Drugs / interventions: chemotherapy
• Locations: 6 sites (Palo Alto, California and 5 other locations)
• Trial ID: NCT05535361 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and potential benefits of the Eclipse XL1 System for distraction enterogenesis in patients with Short Bowel Syndrome. It involves a phased approach, starting with adult subjects and expanding to include pediatric patients. Participants will undergo device placement during a necessary surgical procedure, with follow-up assessments to monitor intestinal lengthening and safety outcomes. The study aims to gather data on the effectiveness of this innovative device in improving intestinal function.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 12 months to 65 years with Short Bowel Syndrome and a minimum residual bowel length of 10 cm.

Not a fit: Patients who have previously undergone intestinal resection or have less than 10 cm of residual bowel length may not benefit from this study.

Why it matters

Potential benefit: If successful, this could provide a new treatment option that enhances intestinal length and function for patients with Short Bowel Syndrome.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in the field of intestinal lengthening, suggesting potential for success.

Eligibility criteria

Inclusion 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).

Exclusion Criteria:

* 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.

Where this trial is running

Palo Alto, California and 5 other locations

• Lucile Packard Children's Hospital Stanford — Palo Alto, California, United States (RECRUITING)
• University of California San Francisco — San Francisco, California, United States (RECRUITING)
• Stanford University School of Medicine — Stanford, California, United States (RECRUITING)
• Children's National Hospital — Washington D.C., District of Columbia, United States (RECRUITING)
• Boston Children's Hospital — Boston, Massachusetts, United States (RECRUITING)
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States (RECRUITING)

Study contacts

• Study coordinator: Andre Bessette

Conditions: Short Bowel Syndrome, short bowel syndrome, intestinal failure, Necrotizing enterocolitis, short gut, intestinal volvulus, intestinal atresia