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
The first phase of the study shall consisted of 5 subjects (aged 18 to 50 years) with an FDA review after 3 subjects with defunctional and functional limbs. Phase 1 initial adult subjects were enrolled and assessed in order to demonstrate an acceptable safety profile. FDA approval was received to advance to subsequent phases of the study.
This next phase (Phase 2) consists of 10 subjects (aged 12 months to 65 years) at 6 centers in the United States.
Device placement will be administered during a previously planned procedure that is otherwise needed by the study subject. Study assessments for the objectives will be collected by radiographic examination to determine length of intestinal lengthening and assessment of safety and clinical improvement until the device is removed or passes out of the intestine naturally. The surgeon shall also review ultrasounds and complete blood counts daily for 7 days post-operatively and weekly post-7 days until device passage or removal to assess for intussusception or infection. Follow up will continue 30 days after the device is removed or naturally passed by the subject. Subjects may or may not be discharged from the hospital while participating in the study, and investigators may recommend that a subject stay in-patient for the entire length of study, depending on subject health