Overweight and Obesity
Conditions
Brief summary
Evaluation of the effect of Epitomee Device on Gastric Emptying Rate in healthy subjects
Detailed description
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.
Interventions
DEVICEEpitomee Device
medical Device designed to enhance the feeling of early satiation and prolonged satiety
Sponsors
Epitomee medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. 21 ≤ Age \<65 years 2. 20 \< BMI ≤ 40 kg/m2 3. Healthy subject 4. Subject is able and willing to give informed consent 5. Subject is able and willing to participate in the study and follow protocol procedures
Exclusion criteria
1. Significant swallowing disorders or difficulty swallowing 2. Suspected GI strictures, fistulas or other GI track obstructions 3. Crohn's disease or diverticulosis 4. Recent GI surgery 5. History of long-standing undigested food in the stomach 6. Known ulcer disease 7. Organic disease associated with gastroparesis such a Parkinson's disease, cerebrovascular accident, neuromuscular disease or eating disorder 8. Presence of a gastrostomy tube or gastric outlet obstruction 9. History or evidence of any active liver disease 10. Allergy to eggs 11. Treatment with anticholinergic or prokinetic agents 12. Treatment with proton-pump inhibitors 13. Hypothyroidism, hyperthyroidism or taking thyroid hormone deficiency drugs (such as L-thyroxine) 14. Prediabetes or Diabetes 15. 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 16. Pregnancy or breastfeeding 17. Currently participating in an ongoing clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Epitomee device on Gastric half-emptying time | 10 days | Change in Gastric half-emptying time |
Countries
Israel
Outcome results
None listed