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Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss.

Primary Purpose

Overweight, Obesity

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Epitomee Device

About this trial

This is an interventional treatment trial for Overweight focused on measuring overweight, obesity

Eligibility Criteria

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

Inclusion Criteria:

21 ≤ Age <65 years
28 < BMI ≤ 40 kg/m2
Healthy subject
Normal blood count and chemistry
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:

A. General health and medication

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
Symptomatic or unbalanced metabolic syndrome, or, symptomatic or unbalanced type 2 diabetes - such patients with minor symptoms may be allowed according to the PI discretion
Intake of chronic medication which may affect the GI or interrupt with the treatment, unless approved by the PI discretion
Taking thyroid hormone deficiency drugs (such as L-thyroxine)
Hemoglobin level under 11 gm/dl
B. Weight loss history and status
Currently using pharmaceutical agents or food supplements for weight loss
History of weight reduction of more than 5% of total body weight in the past 6 months
Eating disorder such as anorexia, bulimia compulsory overeating or emotional eating*
C. Specific GI history and status
History or evidence of any active liver disease. (abnormal liver functions: >1.5 times upper limit)
Subject with Inflammatory Bowel Disease (IBD)
Significant swallowing disorders
Less than 3 natural bowel movements per week
Past history of any gastrointestinal surgery (excluding uncomplicated appendectomy)
Malabsorption disorders
D. General
History of food allergy according to PI decision
Female subjects who are breastfeeding or have a positive pregnancy test at screening or at any time during the study
History of alcohol or drug abuse within 6 months of screening
Mental disorders
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

Arm Description

A non-surgical, non-pharmacologic, medical Device designed to enhance the feeling of satiety. The Device is composed of a 000 size standard capsule and the Tulip's proprietary Device, encapsulated within it. The Device components are produced from approved pharmaceutical excipients / food additives / generally recognized as safe (GRAS )/ food contact materials which are used at high grade

Outcomes

Primary Outcome Measures

Safety evaluation of the Device administration.

Normal Gastroscopic examination as assessed by an independent safety committee.

the change in subjects' weight presented as percent total body loss (%TBL)

Subjects loss of weight described as %TBL

Secondary Outcome Measures

Full Information

NCT ID

NCT03610958

First Posted

July 9, 2018

Last Updated

August 17, 2021

Sponsor

Epitomee medical

1. Study Identification

Unique Protocol Identification Number

NCT03610958

Brief Title

Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss.

Official Title

Prospective, Single Center, Open-labeled Single Arm Study, to Asses the Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss in Healthy Over Weight and Obese Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

September 4, 2014 (Actual)

Primary Completion Date

September 4, 2018 (Actual)

Study Completion Date

September 4, 2018 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Study design to demonstrate the safety and performance of the Epitomee Device

Detailed Description

Prospective, single center, open-labeled single arm study. The subjects will be enrolled in one investigational site. Subjects meeting eligibility criteria will receive multiple capsule intakes, 1 capsule twice daily for 12 weeks.

6. Conditions and Keywords

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

Overweight, Obesity

Keywords

overweight, obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Prospective, single center, open-labeled single arm study.

Masking

None (Open Label)

Allocation

N/A

Enrollment

78 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Epitomee Device arm

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Epitomee Device

Other Intervention Name(s)

Tulip Device

Intervention Description

A non-surgical, non-pharmacologic, medical Device designed to enhance the feeling of satiety.

Primary Outcome Measure Information:

Title

Safety evaluation of the Device administration.

Description

Normal Gastroscopic examination as assessed by an independent safety committee.

Time Frame

Baseline, 12 weeks

Title

the change in subjects' weight presented as percent total body loss (%TBL)

Description

Subjects loss of weight described as %TBL

Time Frame

Baseline, 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 21 ≤ Age <65 years 28 < BMI ≤ 40 kg/m2 Healthy subject Normal blood count and chemistry 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: A. General health and medication 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 Symptomatic or unbalanced metabolic syndrome, or, symptomatic or unbalanced type 2 diabetes - such patients with minor symptoms may be allowed according to the PI discretion Intake of chronic medication which may affect the GI or interrupt with the treatment, unless approved by the PI discretion Taking thyroid hormone deficiency drugs (such as L-thyroxine) Hemoglobin level under 11 gm/dl B. Weight loss history and status Currently using pharmaceutical agents or food supplements for weight loss History of weight reduction of more than 5% of total body weight in the past 6 months Eating disorder such as anorexia, bulimia compulsory overeating or emotional eating* C. Specific GI history and status History or evidence of any active liver disease. (abnormal liver functions: >1.5 times upper limit) Subject with Inflammatory Bowel Disease (IBD) Significant swallowing disorders Less than 3 natural bowel movements per week Past history of any gastrointestinal surgery (excluding uncomplicated appendectomy) Malabsorption disorders D. General History of food allergy according to PI decision Female subjects who are breastfeeding or have a positive pregnancy test at screening or at any time during the study History of alcohol or drug abuse within 6 months of screening Mental disorders 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 participant data for all primary and secondary outcomes measures will be made available

IPD Sharing Time Frame

Data will be available within six months of study completion

Learn more about this trial

Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss.

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