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There is a clear need for a novel method that can readily assess gastric motility in daily clinical practice. Isometric determination of the stomach motility would avoid the use of a large flaccid balloon while still being affordable. The aim of this study was to determine the optimal balloon characteristics that enable to measure motility-induced pressure changes in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Circumference of 13 cm, sphere form (diameter of 4 cm) | Active Comparator |
| |
| Circumference of 13 cm, cylinder form, length 11 cm | Active Comparator |
| |
| Circumference of 16 cm, sphere form (diameter of 5 cm) | Active Comparator |
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| Circumference of 16 cm, cylinder form, length 11 cm | Active Comparator |
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| Circumference of 16 cm, cylinder form, length 18 cm | Active Comparator |
| |
| Circumference of 19 cm, sphere form (diameter of 6 cm) | Active Comparator |
| |
| Circumference of 19 cm, cylinder form, length 11 cm | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balloon characteristics | Device | Different size balloon |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detection of distal stomach-induced contractions using various intragastric balloons | A comparison of various intragastric balloons for the assessment of gastric motility | up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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| Circumference of 22 cm, sphere form (diameter of 7 cm) | Active Comparator |
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| Circumference of 25 cm, sphere form (diameter of 8 cm) | Active Comparator |
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| Circumference of 28 cm, sphere form (diameter of 9 cm) | Active Comparator |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |