MENDD Tolerance Assessment Study

University of Michigan

Status: Terminated

Conditions: Short Bowel Syndrome

Treatments: Device: Double Balloon Endoscope (DBE); Device: Coda® Balloon Catheters

Study type: Interventional

Funder types: Other

Identifiers

NCT06185088

HUM00208413

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Participants with Ostomies

Other group

Description:

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

Treatment:

Device: Coda® Balloon Catheters

Device: Double Balloon Endoscope (DBE)