Short Bowel Syndrome Clinical Trial
Official title:
A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in Adult Patients With Short Bowel Syndrome
The Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System in Adult Patients with Short Bowel Syndrome shall enroll up to 5 Subjects at up to 2 study sites in the United States.
The first phase of the study shall consists 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 will be enrolled and assessed in order to demonstrate an acceptable safety profile. FDA approval will be received before advancing to subsequent phases of the study. 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 ;
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