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

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Epitomee Device
Sponsored by
Epitomee medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Assaf Harofeh Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Epitomee Device

Arm Description

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

Outcomes

Primary Outcome Measures

Evaluation of Epitomee device on Gastric half-emptying time
Change in Gastric half-emptying time

Secondary Outcome Measures

Full Information

First Posted
July 9, 2018
Last Updated
July 23, 2020
Sponsor
Epitomee medical
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1. Study Identification

Unique Protocol Identification Number
NCT04485936
Brief Title
Evaluation of the Effect of Epitomee Device on Gastric Emptying Rate in Healthy Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 9, 2018 (Actual)
Primary Completion Date
April 9, 2019 (Actual)
Study Completion Date
July 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Epitomee medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epitomee Device
Arm Type
Experimental
Arm Description
the participants receive the device which is non-surgical, non-pharmacologic, medical Device designed to enhance the feeling of early satiation and prolonged satiety
Intervention Type
Device
Intervention Name(s)
Epitomee Device
Intervention Description
medical Device designed to enhance the feeling of early satiation and prolonged satiety
Primary Outcome Measure Information:
Title
Evaluation of Epitomee device on Gastric half-emptying time
Description
Change in Gastric half-emptying time
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 21 ≤ Age <65 years 20 < BMI ≤ 40 kg/m2 Healthy subject Subject is able and willing to give informed consent Subject is able and willing to participate in the study and follow protocol procedures Exclusion Criteria: Significant swallowing disorders or difficulty swallowing Suspected GI strictures, fistulas or other GI track obstructions Crohn's disease or diverticulosis Recent GI surgery History of long-standing undigested food in the stomach Known ulcer disease Organic disease associated with gastroparesis such a Parkinson's disease, cerebrovascular accident, neuromuscular disease or eating disorder Presence of a gastrostomy tube or gastric outlet obstruction History or evidence of any active liver disease Allergy to eggs Treatment with anticholinergic or prokinetic agents Treatment with proton-pump inhibitors Hypothyroidism, hyperthyroidism or taking thyroid hormone deficiency drugs (such as L-thyroxine) Prediabetes or Diabetes 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 Pregnancy or breastfeeding Currently participating in an ongoing clinical study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haim Shirin, MD
Organizational Affiliation
The Kamila Gonczarowski Institute of Gastroenterology Assaf Harofeh Medical Center,
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assaf Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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