Michigan ENdoluminal Distraction Device (MENDD) Tolerance Assessment Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Michigan
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Discomfort as Assessed by Visual Analog Scale (VAS) for Radial Stretch
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Participants with Ostomies
Patients who have ostomies, and who are already undergoing a minor procedure for routine health screening or other health matters as standard of care.
Intervention: Coda® Balloon Catheters (Device)
Participants with Ostomies
Patients who have ostomies, and who are already undergoing a minor procedure for routine health screening or other health matters as standard of care.
Intervention: Double Balloon Endoscope (DBE) (Device)
Outcomes
Primary Outcomes
Discomfort as Assessed by Visual Analog Scale (VAS) for Radial Stretch
Time Frame: 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 Outcomes
- Discomfort as Assessed by Visual Analog Scale for Longitudinal Stretch(Approximately 1 minute)
Investigators
Meghan A. Arnold, MD
Clinical Associate Professor
University of Michigan