Status:
TERMINATED
MENDD Tolerance Assessment Study
Lead Sponsor:
University of Michigan
Conditions:
Short Bowel Syndrome
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This study will utilize approved devices in an off-label manner to create forces required to induce intestinal lengthening. Radial and longitudinal forces are both required, and two devices will be us...
Eligibility Criteria
Inclusion
- Existing Ileostomy older than 6 weeks Undergoing any existing procedure in endoscopy suite or operating room.
Exclusion
- Inflammatory bowel disease of small bowel Pregnant Short bowel syndrome Bleeding disorder Chronic pain disorder Individuals taking chronic pain medications including prescriptions, cannabinoids or over the counter.
- Individuals taking pain medications at the time of the procedure Cognitive Impairment to the extent that the questionnaire cannot be completed
Key Trial Info
Start Date :
March 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2023
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT06185088
Start Date
March 6 2023
End Date
June 6 2023
Last Update
October 3 2024
Active Locations (1)
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1
Michigan Medicine
Ann Arbor, Michigan, United States, 48109