Evaluation of the Effect of Epitomee Device on Gastric Emptying Rate in Healthy Subjects

Study Overview
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Brief Summary
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Evaluation of the effect of Epitomee Device on Gastric Emptying Rate in healthy subjects

Detailed Description
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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.

Official Title
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Prospective, Single Center, Open-labeled Single Arm Study of Evaluation of the Effect of Tulip Device on Gastric Emptying Rate in Healthy Subjects

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Device: Epitomee Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21 ≤ Age <65 years 20 < BMI ≤ 40 kg/m2 Healthy subject Subject is able and willing to give informed consent Subject is able and willing to participate in the study and follow protocol procedures Exclusion Criteria: Significant swallowing disorders or difficulty swallowing Suspected GI strictures, fistulas or other GI track obstructions Crohn's disease or diverticulosis Recent GI surgery History of long-standing undigested food in the stomach Known ulcer disease Organic disease associated with gastroparesis such a Parkinson's disease, cerebrovascular accident, neuromuscular disease or eating disorder Presence of a gastrostomy tube or gastric outlet obstruction History or evidence of any active liver disease Allergy to eggs Treatment with anticholinergic or prokinetic agents Treatment with proton-pump inhibitors Hypothyroidism, hyperthyroidism or taking thyroid hormone deficiency drugs (such as L-thyroxine) Prediabetes or Diabetes Any history or evidence of significant cardiac, renal, neurologic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease or symptom which in the judgment of the investigator would interfere with the study or confound the results Pregnancy or breastfeeding Currently participating in an ongoing clinical study

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epitomee Device<br>the participants receive the device which is non-surgical, non-pharmacologic, medical Device designed to enhance the feeling of early satiation and prolonged satiety | Device: Epitomee Device<br>* medical Device designed to enhance the feeling of early satiation and prolonged satiety<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Epitomee device on Gastric half-emptying time | Change in Gastric half-emptying time | 10 days |