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

Launched by ECLIPSE REGENESIS, INC. · Sep 6, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new system called the Eclipse XL1, which may help patients with Short Bowel Syndrome (SBS). SBS occurs when a person has less than half the normal length of bowel, often due to surgery. The study aims to see if using this system is safe and can possibly improve bowel function in both adults and children with this condition. The trial is currently recruiting participants aged between 12 months to 65 years who have at least 10 centimeters of bowel left and are scheduled for a separate abdominal surgery.

To be eligible, participants must have a diagnosis of Short Bowel Syndrome and meet certain health criteria. They should be able to understand the study and provide consent, along with being willing to attend all follow-up visits. Throughout the trial, participants will be monitored for any side effects and the potential benefits of the Eclipse XL1 system. This study is important as it could lead to new treatments for individuals facing the challenges of Short Bowel Syndrome, helping improve their quality of life.

Gender

ALL

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 10 cm.
• • Male or female patients aged 12 months to 65 years inclusive
• • Subject has scheduled open abdominal procedure for different indication than study device (i.e., ostomy take-down, stoma-take-down, open liver biopsy, and procedures to 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 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:
• • Previously performed intestinal resection and/or bowel lengthening procedure \< 6 months 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 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.