Clinical trial NCT03610958: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: overweight
obesity
Lead sponsor: Epitomee medical
Sponsor class: INDUSTRY
First posted: 2018-08-01
Enrollment: 78
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, single center, open-labeled single arm study.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety evaluation of the Device administration.
timeFrame: Baseline, 12 weeks
measure: the change in subjects' weight presented as percent total body loss (%TBL)
timeFrame: Baseline, 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
Study officials:
affiliation: The Kamila Gonczarowski Institute of Gastroenterology Assaf Harofeh Medical Center,
name: Haim Shirin, MD
role: PRINCIPAL_INVESTIGATOR
References: