MENDD Tolerance Assessment Study

Stopped early · Not applicable

Conditions studied: Short Bowel Syndrome

In brief

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 used to create forces in order to test tolerability of said forces. This is to provide evidence that humans could tolerate the forces produced by a proposed commercially built device. This study will test the hypothesis that radial and longitudinal forces necessary to produce enterogenesis will cause low levels of discomfort in healthy adults. Approved devices will be utilized in an off-label manner to reproduce forces similar to our novel medical device which is designed to treat short bowel syndrome (SBS). This trial will not be testing a treatment for SBS, and individuals with SBS are ineligible for recruitment.

Key facts

Study ID

NCT06185088

Run by

University of Michigan

People needed

1

Starts

2023-03-06

Expected to finish

2023-06-06

Last updated by the study team

2024-10-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Existing Ileostomy older than 6 weeks Undergoing any existing procedure in endoscopy suite or operating room.

You may not qualify if…

• 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

Where it is running

• Michigan Medicine — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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