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Participants with Ostomies for Short Bowel Syndrome

N/A

Recruiting

Led By Meghan A Arnold, MD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing any existing procedure in endoscopy suite or operating room.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-2 minutes

Awards & highlights

Study Summary

This trial will use approved devices in a different way to create forces needed to make the intestines longer. They want to see if the forces are tolerable for humans. They are not testing a treatment

Who is the study for?

This trial is for adults with an ileostomy older than 6 weeks who are already scheduled for a procedure in the endoscopy suite or operating room. It's not for those with inflammatory bowel disease, pregnant women, people with short bowel syndrome, bleeding disorders, chronic pain disorders, or those on pain medications including prescriptions and over-the-counter drugs.Check my eligibility

What is being tested?

The study tests how well healthy adults can tolerate forces that could lead to intestinal lengthening using two approved devices off-label: Coda® Balloon Catheters and Double Balloon Endoscope (DBE). The goal is to simulate the effects of a new device designed to treat Short Bowel Syndrome without actually treating it.See study design

What are the potential side effects?

Since this trial involves mechanical procedures rather than medication, side effects may include discomfort or pain at the site of intervention due to the application of radial and longitudinal forces by the catheters and endoscope.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for a procedure in the endoscopy suite or operating room.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-2 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-2 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-2 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Discomfort as Assessed by Visual Analog Scale (VAS) for Radial Stretch

Secondary outcome measures

Discomfort as Assessed by Visual Analog Scale for Longitudinal Stretch

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants with OstomiesExperimental Treatment2 Interventions

Patients who have ostomies, and who are already undergoing a minor procedure for routine health screening or other health matters as standard of care.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,798 Previous Clinical Trials

6,378,133 Total Patients Enrolled

1 Trials studying Short Bowel Syndrome

10 Patients Enrolled for Short Bowel Syndrome

Meghan A Arnold, MDPrincipal InvestigatorUniversity of Michigan

1 Previous Clinical Trials

22 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit for patient enrollment in this particular clinical investigation?

"Indeed, the details on clinicaltrials.gov indicate that this trial is currently in search of eligible participants. The study was initially posted on March 6th, 2023 and last updated on December 14th, 2023. To complete the trial successfully, a total of five individuals will be enrolled at one specific location."

Answered by AI

Are potential participants currently able to apply for enrollment in this trial?

"According to the information available on clinicaltrials.gov, this ongoing trial is actively seeking eligible participants. The study was initially posted for recruitment on March 6th, 2023 and has undergone its most recent update on December 14th, 2023."

Answered by AI

Is this medical study open to individuals who are older than 25 years of age?

"To be considered eligible for this trial, applicants must fall within the age range of 18 to 80. Additionally, there are separate studies available for patients under the age of 18 (3 studies) and those over the age of 65 (11 studies)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

MENDD Tolerance Assessment Study

Meghan A. Arnold, MD 2023. "MENDD Tolerance Assessment Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06185088.