RecruitingNot ApplicableNCT05535361

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


Sponsor

Eclipse Regenesis, Inc.

Enrollment

40 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 3 MonthsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a device called the Eclipse XL1 System for people with short bowel syndrome (SBS) — a condition where much of the small intestine is missing or has been removed, making it very hard to absorb nutrients. The device works by gradually stretching the remaining intestine to help it grow longer and absorb more nutrients, reducing the need for IV nutrition. **You may be eligible if:** - You have short bowel syndrome, meaning you have 50% or less of the expected bowel length for your age or height - You have at least 3 cm of remaining bowel - You are between 3 months and 65 years old - You or your legal guardian can give informed consent and attend all study visits **You may NOT be eligible if:** - You have less than 3 cm of remaining bowel (ultra-short bowel syndrome) - You have Crohn's disease or another inflammatory bowel disease - You have active serious infections or other conditions that make surgery unsafe Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDistraction Enterogenesis in Adult Patients with Short Bowel Syndrome

The surgeon verifies the intestinal diameter and selects the appropriate device diameter size. The device is introduced into the lumen of the intestine and advanced about 5-10cm. The surgeon uses 4-0 chromic sutures placed in the seromuscular layer to secure the XL1 Coil within the intestine. The surgeon places metal clips on proximal and distal sutures and in the mesentery adjacent to the XL1 Coil ends to mark the location for radiologic evaluation. The surgeon releases the XL1 Coil and closes the enterotomy.


Locations(6)

Lucile Packard Children's Hospital Stanford

Palo Alto, California, United States

University of California San Francisco

San Francisco, California, United States

Stanford University School of Medicine

Stanford, California, United States

Children's National Hospital

Washington D.C., District of Columbia, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

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NCT05535361


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