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

Not Applicable

Not yet recruiting

• Conditions: Short Bowel Syndrome

• Registration Number: NCT05535361
• Lead Sponsor: Eclipse Regenesis, Inc.

Brief 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

Detailed 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 12 months to 21 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.

Study Timeline

• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-06
• Study First Posted: 2022-09-10
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-08
• Study Start: 2025-09-15
• Last Update Posted: 2025-09-15
• Primary Completion: 2028-03-01
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 10 cm.
• Male or female patients aged 12 mo to 21 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 10 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Device and procedure related adverse events	4 to 6 months	Incident rate of moderate or severe procedure and/or device related adverse events

Secondary Outcome Measures

Name	Time	Method
Improvement in overall nutritional status	6 to 12 months	Improvement in overall nutritional status at 6 months post final implantation compared to pre-procedure as evidenced by change in parenteral, enteral, oral intake; stool frequency and quality; weight.
Assess the lengthening of the small intestine	4 to 6 months	Assess the lengthening of the small intestine via the Eclipse XL1 Coil.

Trial Locations

Locations (4)

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

Cincinnati Children's Hospital; 🇺🇸 Cincinnati, Ohio, United States