Phase
Condition
Bowel Dysfunction
Treatment
Distraction Enterogenesis in Adult Patients with Short Bowel Syndrome
Clinical Study ID
Ages 12-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject has short bowel syndrome, defined as 50% or less of expected bowel lengthbased on subject age and/or height, and measured at the time of the subject's priorintestinal resection.
Minimum residual bowel length of 10 cm.
Male or female patients aged 12 months to 65 years inclusive
Subject has scheduled open abdominal procedure for different indication than studydevice (i.e., ostomy take-down, stoma-take-down, open liver biopsy, and proceduresto 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 therequirements of the study and is willing to bring the subject to all clinic visitsand complete all study related procedures (as determined by the investigator).
Exclusion
Exclusion Criteria:
Previously performed intestinal resection and/or bowel lengthening procedure < 6months 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 ulcerativecolitis)
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 haveundergone organ transplantation, chemotherapy or radiotherapy within the past 12months, who have clinically significant leukopenia, who are positive for the humanimmunodeficiency virus (HIV) or whose immune status makes the subject a poorcandidate for clinical trial participation in the opinion of the Investigator.
Subject is determined by the investigator to be unsuitable for participation in thistrial for any reason.
Study Design
Study Description
Connect with a study center
Stanford University School of Medicine
Stanford, California 94304
United StatesActive - Recruiting
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