MENDD Tolerance Assessment Study

Study Overview
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Brief Summary
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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.

Official Title
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Michigan ENdoluminal Distraction Device (MENDD) Tolerance Assessment Study

Conditions
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Short Bowel Syndrome

Intervention / Treatment
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* Device: Coda® Balloon Catheters
* Device: Double Balloon Endoscope (DBE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Existing Ileostomy older than 6 weeks Undergoing any existing procedure in endoscopy suite or operating room. Exclusion Criteria: Inflammatory bowel disease of small bowel Pregnant Short bowel syndrome Bleeding disorder Chronic pain disorder Individuals taking chronic pain medications including prescriptions, cannabinoids or over the counter. Individuals taking pain medications at the time of the procedure Cognitive Impairment to the extent that the questionnaire cannot be completed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Participants with Ostomies<br>Patients who have ostomies, and who are already undergoing a minor procedure for routine health screening or other health matters as standard of care. | Device: Coda® Balloon Catheters<br>* A balloon device that will be introduced into participants' intestine over a guide wire to test the radial stretch of the small bowel.<br>Device: Double Balloon Endoscope (DBE)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discomfort as Assessed by Visual Analog Scale (VAS) for Radial Stretch | Participant discomfort will be assessed using VAS during radial stretch. The VAS is a scale ranging from 0 (no pain) to 10 (maximum pain). | 1-2 Minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discomfort as Assessed by Visual Analog Scale for Longitudinal Stretch | Participant discomfort will be assessed using VAS during longitudinal stretch. The VAS is a scale ranging from 0 (no pain) to 10 (maximum pain). | Approximately 1 minute |