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NCT06185088 · ClinicalTrials.gov registry record · NA
MENDD Tolerance Assessment Study
A NA study, sponsored by University of Michigan.
- Terminated
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT06185088: Clinical Trial NA study, sponsored by University of Michigan.
NCT06185088 is a NA study that was terminated before completion, run by University of Michigan. The registered enrollment target is 1 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06185088, a NA study, was terminated before completion, sponsored by University of Michigan.
- TERMINATED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study 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.
Primary Outcome
Participant discomfort will be assessed using VAS during radial stretch. The VAS is a scale ranging from 0 (no pain) to 10 (maximum pain).
Interventions
- DEVICE Coda® Balloon Catheters
- DEVICE Double Balloon Endoscope (DBE)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2023-03-06 |
| Est. Completion | 2023-06-06 |
| Phase | NA |
Why NCT06185088 stopped before completion
NCT06185088 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Coda® Balloon Catheters is the first listed.
NCT06185088 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06185088 about?
NCT06185088 is a clinical study titled "MENDD Tolerance Assessment Study". 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 h...
What is the current status of trial NCT06185088?
This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2023-03-06. Estimated completion is 2023-06-06.
What interventions are being tested in trial NCT06185088?
The interventions under investigation include: Coda® Balloon Catheters (DEVICE), Double Balloon Endoscope (DBE) (DEVICE).
Who is sponsoring clinical trial NCT06185088?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06185088's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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