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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.
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
Key Details
Gender
All
Age Range
3 Months - 65 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-09-15
Completion Date
2028-06-30
Last Updated
2025-10-08
Healthy Volunteers
No
Conditions
Interventions
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.
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