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Initial PI departed institution.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Ostomies | Other | Patients who have ostomies, and who are already undergoing a minor procedure for routine health screening or other health matters as standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coda® Balloon Catheters | Device | A balloon device that will be introduced into participants' intestine over a guide wire to test the radial stretch of the small bowel. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 1-2 Minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Approximately 1 minute |
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Inclusion Criteria:
Exclusion Criteria:
Individuals taking pain medications at the time of the procedure Cognitive Impairment to the extent that the questionnaire cannot be completed
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| Name | Affiliation | Role |
|---|---|---|
| Meghan A Arnold, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan Medicine | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Because only one participant was involved in the entire trial, showing data could violate privacy interests. | Posted | 1-2 Minutes |
|
30 days
Because only one participant was involved in the entire trial, showing data could violate privacy interests.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meghan Arnold | University of Michigan | 734-936-8978 | meghanar@med.umich.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 4, 2023 | Sep 7, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D012778 | Short Bowel Syndrome |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Double Balloon Endoscope (DBE) | Device | 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. |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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). | Because only one participant was involved in the entire trial, showing data could violate privacy interests. | Posted | Approximately 1 minute |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |