MENDD Tolerance Assessment Study

Not Applicable

Terminated

• Conditions: Short Bowel Syndrome

• Registration Number: NCT06185088
• Lead Sponsor: University of Michigan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-06
• Primary Completion: 2023-06-06
• Study Completion: 2023-06-06
• Study First Submitted: 2023-12-14
• Study First Submitted QC: 2023-12-14
• Study First Posted: 2023-12-29
• Results First Submitted: 2024-07-30
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-09
• Last Update Submitted: 2024-09-09
• Results First Posted: 2024-10-03
• Last Update Posted: 2024-10-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Michigan Medicine; 🇺🇸 Ann Arbor, Michigan, United States