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

Not Applicable

Completed

• Conditions: Overweight and Obesity
• Interventions: Device: Epitomee Device

• Registration Number: NCT04485936
• Lead Sponsor: Epitomee medical

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.

Study Timeline

• Study Start: 2018-04-09
• Study First Submitted: 2018-07-09
• Primary Completion: 2019-04-09
• Study Completion: 2019-07-09
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-23
• Last Update Submitted: 2020-07-23
• Study First Posted: 2020-07-24
• Last Update Posted: 2020-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epitomee Device	Epitomee Device	the participants receive the device which is non-surgical, non-pharmacologic, medical Device designed to enhance the feeling of early satiation and prolonged satiety

Primary Outcome Measures

Name	Time	Method
Evaluation of Epitomee device on Gastric half-emptying time	10 days	Change in Gastric half-emptying time

Trial Locations

Locations (1)

Assaf Harofeh Medical Center; 🇮🇱 Zerifin, Israel