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

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04485936
• Other study ID #: PRT-05-030
• Status: Completed
• Phase: N/A
• Start date: April 9, 2018
• Est. completion date: July 9, 2019

Study information

• Verified date: July 2020
• Source: Epitomee medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of the effect of Epitomee Device on Gastric Emptying Rate in healthy subjects

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 9, 2019
• Est. primary completion date: April 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Device:
• Epitomee Device
medical Device designed to enhance the feeling of early satiation and prolonged satiety

Locations

Country	Name	City	State
Israel	Assaf Harofeh Medical Center	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Epitomee medical

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Epitomee device on Gastric half-emptying time	Change in Gastric half-emptying time	10 days