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MENDD Tolerance Assessment Study

NCT06185088 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2024-10-03

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Meghan A Arnold, MD · University of Michigan

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-06
Primary Completion
2023-06-06
Completion
2023-06-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06185088 on ClinicalTrials.gov