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Evaluation of the effect of Epitomee Device on Gastric Emptying Rate in healthy subjects
The participants will be enrolled in one investigational site. Subjects meeting eligibility criteria will undergo a gastric emptying test using gastric scintigraphy before any treatment (baseline).
Following the scintigraphy, the subjects will receive Tulip Device treatment - 2 capsules/day.
After repeated capsule intake for either 4 or 11 or 28 days, the subjects will undergo additional gastric emptying test with a capsule intake prior to the test meal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epitomee Device | Experimental | the participants receive the device which is non-surgical, non-pharmacologic, medical Device designed to enhance the feeling of early satiation and prolonged satiety |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epitomee Device | Device | medical Device designed to enhance the feeling of early satiation and prolonged satiety |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Epitomee device on Gastric half-emptying time | Change in Gastric half-emptying time | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haim Shirin, MD | The Kamila Gonczarowski Institute of Gastroenterology Assaf Harofeh Medical Center, | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assaf Harofeh Medical Center | Ẕerifin | 70300 | Israel |
De-identified individual participants data for all primary and secondary outcome measures will be made available
Data will be available within six months of study completion
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |