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

NCT ID: NCT04485936

Last Updated: 2020-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-09
• Study Completion Date: 2019-07-09

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.

Conditions

Overweight and Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Epitomee Device

Intervention Type: DEVICE

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

Interventions

Epitomee Device

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Epitomee medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Haim Shirin, MD

Role: PRINCIPAL_INVESTIGATOR

The Kamila Gonczarowski Institute of Gastroenterology Assaf Harofeh Medical Center,

Locations

Assaf Harofeh Medical Center

Ẕerifin, , Israel

Countries

Israel

Other Identifiers

PRT-05-030

Identifier Type: -

Identifier Source: org_study_id