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

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 design to demonstrate the safety and performance of the Epitomee Device

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 21 ≤ Age <65 years
2. 28 < BMI ≤ 40 kg/m2
3. Healthy subject
4. Normal blood count and chemistry
5. Subject is able and willing to give informed consent
6. Subject is able and willing to participate in the study and follow protocol procedures

Exclusion Criteria:

A. General health and medication

1. 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
2. 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
3. Intake of chronic medication which may affect the GI or interrupt with the treatment, unless approved by the PI discretion
4. Taking thyroid hormone deficiency drugs (such as L-thyroxine)

5. Hemoglobin level under 11 gm/dl

   B. Weight loss history and status

6. Currently using pharmaceutical agents or food supplements for weight loss
7. History of weight reduction of more than 5% of total body weight in the past 6 months

8. Eating disorder such as anorexia, bulimia compulsory overeating or emotional eating*

   C. Specific GI history and status

9. History or evidence of any active liver disease. (abnormal liver functions: >1.5 times upper limit)
10. Subject with Inflammatory Bowel Disease (IBD)
11. Significant swallowing disorders
12. Less than 3 natural bowel movements per week
13. Past history of any gastrointestinal surgery (excluding uncomplicated appendectomy)

14. Malabsorption disorders

    D. General

15. History of food allergy according to PI decision
16. Female subjects who are breastfeeding or have a positive pregnancy test at screening or at any time during the study
17. History of alcohol or drug abuse within 6 months of screening
18. Mental disorders
19. 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 arm; 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

Device: Epitomee Device; A non-surgical, non-pharmacologic, medical Device designed to enhance the feeling of satiety.; Other Names: Tulip Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety evaluation of the Device administration.	Normal Gastroscopic examination as assessed by an independent safety committee.	Baseline, 12 weeks
the change in subjects' weight presented as percent total body loss (%TBL)	Subjects loss of weight described as %TBL	Baseline, 12 weeks

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): September 4, 2014
• Primary Completion (Actual): September 4, 2018
• Study Completion (Actual): September 4, 2018

Study Registration Dates

• First Submitted: July 9, 2018
• First Submitted That Met QC Criteria: July 26, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: obesity; overweight
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Overweight
• Other Study ID Numbers: PRT-05-022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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
• IPD Sharing Supporting Information Type: Study Protocol; Clinical Study Report (CSR)

Drug and device information, study documents

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