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

Epitomee Medical

Status: Completed

Conditions: Overweight; Obesity

Treatments: Device: Epitomee Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT03610958

PRT-05-022

Details and patient eligibility

About

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

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 1 patient group

Epitomee Device arm

Experimental group

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

Treatment:

Device: Epitomee Device