Obesity, Overweight
Conditions
Keywords
overweight, obesity
Brief summary
Study design to demonstrate the safety and performance of the Epitomee Device
Detailed description
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.
Interventions
DEVICEEpitomee Device
A non-surgical, non-pharmacologic, medical Device designed to enhance the feeling of satiety.
Sponsors
Epitomee medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, single center, open-labeled single arm study.
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. 21 ≤ Age \<65 years 2. 28 \< BMI ≤ 40 kg/m2 3. Healthy subject 4. Normal blood count and chemistry 5. Subject is able and willing to give informed consent 6. Subject is able and willing to participate in the study and follow protocol procedures
Exclusion criteria
A. General health and medication 1. 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 2. 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 3. Intake of chronic medication which may affect the GI or interrupt with the treatment, unless approved by the PI discretion 4. Taking thyroid hormone deficiency drugs (such as L-thyroxine) 5. Hemoglobin level under 11 gm/dl B. Weight loss history and status 6. Currently using pharmaceutical agents or food supplements for weight loss 7. History of weight reduction of more than 5% of total body weight in the past 6 months 8. Eating disorder such as anorexia, bulimia compulsory overeating or emotional eating\* C. Specific GI history and status 9. History or evidence of any active liver disease. (abnormal liver functions: \>1.5 times upper limit) 10. Subject with Inflammatory Bowel Disease (IBD) 11. Significant swallowing disorders 12. Less than 3 natural bowel movements per week 13. Past history of any gastrointestinal surgery (excluding uncomplicated appendectomy) 14. Malabsorption disorders D. General 15. History of food allergy according to PI decision 16. Female subjects who are breastfeeding or have a positive pregnancy test at screening or at any time during the study 17. History of alcohol or drug abuse within 6 months of screening 18. Mental disorders 19. Currently participating in an ongoing clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety evaluation of the Device administration. | Baseline, 12 weeks | Normal Gastroscopic examination as assessed by an independent safety committee. |
| the change in subjects' weight presented as percent total body loss (%TBL) | Baseline, 12 weeks | Subjects loss of weight described as %TBL |
Countries
Israel
Outcome results
None listed