NCT06185088

MENDD Tolerance Assessment Study

Terminated NA Results posted Last updated 3 October 2024

What this trial tests

NA trial testing Coda® Balloon Catheters in Short Bowel Syndrome in 1 participant. Terminated before completion.

Timeline

6 March 2023

Primary endpoint
6 June 2023

6 June 2023

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	1
Start date	6 March 2023
Primary completion	6 June 2023
Estimated completion	6 June 2023
Sites	1 location across United States

Drugs / interventions tested

• Coda® Balloon Catheters
• Double Balloon Endoscope (DBE)

Conditions studied

• Short Bowel Syndrome — all drugs for Short Bowel Syndrome →

Sponsor

University of Michigan

Who can join

Adults 18 to 80, any sex, with Short Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.