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).
Single group
Distraction Enterogenesis in Adult Patients with Short Bowel Syndrome
DeviceThe 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.
Device and procedure related adverse events
Incident rate of moderate or severe procedure and/or device related adverse events
Assess the lengthening of the small intestine
Assess the lengthening of the small intestine via the Eclipse XL1 Coil.
Improvement in overall nutritional status
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.
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Eclipse Regenesis, Inc.
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Children's Hospital Medical Center, Cincinnati
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
