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
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.
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).
Eclipse Regenesis, Inc.
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Children's Hospital Medical Center, Cincinnati
Collaborator
Stanford University
Collaborator
University of California, San Francisco
Collaborator
Boston Children's Hospital
Collaborator
Lucile Packard Children's Hospital at Stanford
Collaborator
Children's National Health System, Washington DC
Collaborator