MENDD Tolerance Assessment Study

Not Applicable

Terminated

Interventions: Device: Coda® Balloon Catheters
Device: Double Balloon Endoscope (DBE)

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Participants with Ostomies	Coda® Balloon Catheters	Patients who have ostomies, and who are already undergoing a minor procedure for routine health screening or other health matters as standard of care.
Participants with Ostomies	Double Balloon Endoscope (DBE)	Patients who have ostomies, and who are already undergoing a minor procedure for routine health screening or other health matters as standard of care.

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).