A Feasibility Study to Evaluate Safety & Benefit of Eclipse XL1 System in Adult Patients With SBS
Trial ID or NCT#
NCT05535361
Status
NOT RECRUITING
Purpose
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.
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
Eligibility Criteria
Ages Eligible for Study: 18 Years to 50 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- - Subject has short bowel syndrome, defined as 50% or less of expected bowel length based on subject age and/or height, and measured at the time of the subject's prior intestinal resection. - Minimum residual bowel length of 10 cm. - Male or female patients aged 18 to 50 years inclusive - Subject has scheduled open abdominal procedure for different indication than study device (i.e., ostomy take-down, stoma-take-down, open liver biopsy, and procedures to correct the following: bowel obstruction, strictures, adhesions). - The subject, parent or legal guardian of the subject is able to read, understand, and is willing to provide informed consent. - The subject or parent or legal guardian of the patient is able to understand the requirements of the study and is willing to bring the subject to all clinic visits and complete all study related procedures (as determined by the investigator).
Exclusion Criteria:
- - Previously performed intestinal resection and/or bowel lengthening procedure < 6 months from screening visit. - Ultra-short bowel syndrome defined as less than 10 cm of bowel length. - Diagnosed Inflammatory bowel disease-unclassified (not Crohn's or ulcerative colitis) - Evidence of active or prior Crohn's disease. - Primary intestinal failure (i.e., without loss or resection of intestinal tissue). - Coagulopathy, as defined by INR > 1.4 or platelets < 100. - Known immunocompromised status including, but not limited to, individuals who have undergone organ transplantation, chemotherapy or radiotherapy within the past 12 months, who have clinically significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the subject a poor candidate for clinical trial participation in the opinion of the Investigator. - Subject is determined by the investigator to be unsuitable for participation in this trial for any reason.
Investigator(s)
Shweta S. Namjoshi MD MPH
Clinical Associate Professor, Pediatrics - Gastroenterology
Joseph (Joe) D Forrester MD MSc FAWM FACS
Trauma and critical care surgeon,
General surgeon
Assistant Professor of Surgery (General Surgery)
View on ClinicalTrials.gov
