NCT06185088

MENDD Tolerance Assessment Study

Michigan ENdoluminal Distraction Device (MENDD) Tolerance Assessment Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Short Bowel Syndrome

Interventions

Type	Name	Description
DEVICE	Coda® Balloon Catheters	A balloon device that will be introduced into participants' intestine over a guide wire to test the radial stretch of the small bowel.
DEVICE	Double Balloon Endoscope (DBE)	A balloon device that will be introduced retrograde through the ileostomy and the inter-balloon distance will be increased causing stretch on the intestine to test longitudinal stretch. The DBE will only be used if a participant tolerated the Coda® Balloon Catheter intervention.

Timeline

• Start date: 2023-03-06
• Primary completion: 2023-06-06
• Completion: 2023-06-06
• First posted: 2023-12-29
• Last updated: 2024-10-03
• Results posted: 2024-10-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study