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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03610958
• Other study ID #: PRT-05-022
• Status: Completed
• Phase: N/A
• Start date: September 4, 2014
• Est. completion date: September 4, 2018

Study information

• Verified date: August 2021
• Source: Epitomee medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: September 4, 2018
• Est. primary completion date: September 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
Israel	Assaf Harofeh Medical Center	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Epitomee medical

Country where clinical trial is conducted

Israel, 

Outcome

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