Evaluating the Eclipse XL1 System for Intestinal Growth in Children and Adults with Short Bowel Syndrome

What this Trial Is About

Researchers are evaluating the safety and potential benefits of the Eclipse XL1 System in both children and adults who have short bowel syndrome, a condition where part of the small intestine is missing or has been removed. This single-group, open-label clinical study includes participants aged from 3 months to 65 years old and is conducted across multiple sites in the United States to better understand how this device might help with intestinal growth. The study involves placing the Eclipse XL1 device inside the intestine during either a standalone surgery or an already planned procedure. Participants may receive up to two devices simultaneously or undergo multiple procedures if needed. The device is secured inside the intestine and marked with metal clips to monitor its position. Researchers will track how the device affects intestinal lengthening and nutritional status over time, and the device will be observed through imaging until it is removed or naturally passes out. Participants will be monitored while the device is in place and followed up at 3 and 6 months after the device is removed or passes naturally. During the study, their nutrition, weight, and stool will be assessed, and radiographic exams will confirm device placement and safety. Depending on their health, subjects may stay in the hospital or be discharged while participating. The total study duration allows for careful evaluation of device-related adverse events and improvements in intestinal health.

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