Short Bowel Syndrome
Conditions
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.
Interventions
DEVICECoda® 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.
DEVICEDouble 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.
Sponsors
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Participants With Ostomies |
|---|---|
| Age, Customized 18 years to 99 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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).
Time frame: 1-2 Minutes
Population: Because only one participant was involved in the entire trial, showing data could violate privacy interests.
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).
Time frame: Approximately 1 minute
Population: Because only one participant was involved in the entire trial, showing data could violate privacy interests.