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

NCT03610958 | Completed DMC

• 1 other identifier: PRT-05-022
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Overweight; Obesity

Keywords

overweight; obesity

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Epitomee Device arm

EXPERIMENTAL

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

Interventions

Epitomee Device DEVICE

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

Also known as: Tulip Device

Epitomee Device arm

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ Age \<65 years
• \< 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Epitomee medical: lead

Study Sites (1)

Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Haim Shirin, MD

  The Kamila Gonczarowski Institute of Gastroenterology Assaf Harofeh Medical Center,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, single center, open-labeled single arm study.

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: August 1, 2018
• Study Start: September 4, 2014
• Primary Completion: September 4, 2018
• Study Completion: September 4, 2018
• Last Updated: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will be available within six months of study completion

Locations

IL (1)