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

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

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

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Device: Epitomee Device

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Zerifin, Israel, 70300
    • Assaf Harofeh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: Epitomee Device; medical Device designed to enhance the feeling of early satiation and prolonged satiety

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Epitomee device on Gastric half-emptying time	Change in Gastric half-emptying time	10 days

Collaborators and Investigators

• Sponsor: Epitomee medical
• Investigators: Principal Investigator: Haim Shirin, MD, The Kamila Gonczarowski Institute of Gastroenterology Assaf Harofeh Medical Center,

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2018
• Primary Completion (Actual): April 9, 2019
• Study Completion (Actual): July 9, 2019

Study Registration Dates

• First Submitted: July 9, 2018
• First Submitted That Met QC Criteria: July 23, 2020
• First Posted (Actual): July 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 24, 2020
• Last Update Submitted That Met QC Criteria: July 23, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: PRT-05-030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified individual participants data for all primary and secondary outcome measures will be made available
• IPD Sharing Time Frame: Data will be available within six months of study completion
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No