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

Sponsor

Epitomee medical (Industry)

Overall Status

Completed

CT.gov ID

NCT04485936

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity	Device: Epitomee Device	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 9, 2018

Actual Primary Completion Date :

Apr 9, 2019

Actual Study Completion Date :

Jul 9, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Evaluation of Epitomee device on Gastric half-emptying time [10 days]
Change in Gastric half-emptying time

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assaf Harofeh Medical Center	Zerifin		Israel	70300

Sponsors and Collaborators

Epitomee medical

Investigators

Principal Investigator: Haim Shirin, MD, The Kamila Gonczarowski Institute of Gastroenterology Assaf Harofeh Medical Center,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Epitomee medical

ClinicalTrials.gov Identifier:

NCT04485936

Other Study ID Numbers:

PRT-05-030

First Posted:

Jul 24, 2020

Last Update Posted:

Jul 24, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Overweight

Study Results

No Results Posted as of Jul 24, 2020