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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 is a NA study that was terminated before completion, run by University of Michigan. The registered enrollment target is 1 participants.

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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.

Interventions

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

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2023-03-06
Est. Completion 2023-06-06
Phase NA

Sponsor

University of Michigan

1,327 total trials

What the Registry Record Tells You About NCT06185088

The ClinicalTrials.gov registry entry for NCT06185088 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Coda® Balloon Catheters is the first listed.

NCT06185088 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.