MENDD Tolerance Assessment Study

Short Bowel Syndrome Clinical Trial

Official title:

Michigan ENdoluminal Distraction Device (MENDD) Tolerance Assessment Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06185088
• Other study ID #: HUM00208413
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2023
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: University of Michigan
• Contact: Sarah Fox
• Phone: (734) 232-8005
• Email: sarasort[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Short Bowel Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Michigan Medicine	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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