Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss.

Study Overview
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Brief Summary
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Study design to demonstrate the safety and performance of the Epitomee Device

Detailed Description
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Prospective, single center, open-labeled single arm study. The subjects will be enrolled in one investigational site. Subjects meeting eligibility criteria will receive multiple capsule intakes, 1 capsule twice daily for 12 weeks.

Official Title
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Prospective, Single Center, Open-labeled Single Arm Study, to Asses the Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss in Healthy Over Weight and Obese Subjects

Conditions
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Overweight, 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 28 < BMI ≤ 40 kg/m2 Healthy subject Normal blood count and chemistry 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: A. General health and medication 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 Symptomatic or unbalanced metabolic syndrome, or, symptomatic or unbalanced type 2 diabetes - such patients with minor symptoms may be allowed according to the PI discretion Intake of chronic medication which may affect the GI or interrupt with the treatment, unless approved by the PI discretion Taking thyroid hormone deficiency drugs (such as L-thyroxine) Hemoglobin level under 11 gm/dl B. Weight loss history and status Currently using pharmaceutical agents or food supplements for weight loss History of weight reduction of more than 5% of total body weight in the past 6 months Eating disorder such as anorexia, bulimia compulsory overeating or emotional eating* C. Specific GI history and status History or evidence of any active liver disease. (abnormal liver functions: >1.5 times upper limit) Subject with Inflammatory Bowel Disease (IBD) Significant swallowing disorders Less than 3 natural bowel movements per week Past history of any gastrointestinal surgery (excluding uncomplicated appendectomy) Malabsorption disorders D. General History of food allergy according to PI decision Female subjects who are breastfeeding or have a positive pregnancy test at screening or at any time during the study History of alcohol or drug abuse within 6 months of screening Mental disorders 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
Interventional Model Description: Prospective, single center, open-labeled single arm study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epitomee Device arm<br>A non-surgical, non-pharmacologic, medical Device designed to enhance the feeling of satiety. The Device is composed of a 000 size standard capsule and the Tulip's proprietary Device, encapsulated within it. The Device components are produced from approved pharmaceutical excipients / food additives / generally recognized as safe (GRAS )/ food contact materials which are used at high grade | Device: Epitomee Device<br>* A non-surgical, non-pharmacologic, medical Device designed to enhance the feeling of satiety.<br>* Other names: Tulip Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluation of the Device administration. | Normal Gastroscopic examination as assessed by an independent safety committee. | Baseline, 12 weeks | 
| the change in subjects' weight presented as percent total body loss (%TBL) | Subjects loss of weight described as %TBL | Baseline, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, overweight