40
Participants
Start Date
September 15, 2025
Primary Completion Date
March 1, 2028
Study Completion Date
June 30, 2028
Distraction 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.
RECRUITING
Children's National Hospital, Washington D.C.
RECRUITING
University of California San Francisco, San Francisco
RECRUITING
Lucile Packard Children's Hospital Stanford, Palo Alto
RECRUITING
Stanford University School of Medicine, Stanford
RECRUITING
Boston Children's Hospital, Boston
RECRUITING
Cincinnati Children's Hospital, Cincinnati
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Children's Hospital Medical Center, Cincinnati
OTHER
Stanford University
OTHER
University of California, San Francisco
OTHER
Boston Children's Hospital
OTHER
Lucile Packard Children's Hospital at Stanford
UNKNOWN
Children's National Health System, Washington DC
UNKNOWN
Eclipse Regenesis, Inc.
OTHER