Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL
Official Title: Michigan ENdoluminal Distraction Device (MENDD) Tolerance Assessment Study
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 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.