OverweightNCT03610958
Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss.
A study testing Epitomee Device in people with Overweight and Obesity, run by Epitomee medical at 1 site in Israel.
Trial summary
Study design to demonstrate the safety and performance of the Epitomee Device Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Epitomee Device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteIsrael
- Study dates
- 4 Sep 2014to 4 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 21 ≤ Age <65 years
- 28 < 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
Who cannot join
- 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
Show all 23Show fewer
- 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*
- 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
- Past history of any gastrointestinal surgery (excluding uncomplicated appendectomy)
- Malabsorption disorders
- General
- History of food allergy according to PI decision
- Female subjects who are breastfeeding or have a positive pregnancy test at screening or at any time during the study
- History of alcohol or drug abuse within 6 months of screening
- Mental disorders
- Currently participating in an ongoing clinical study
Trial locations and contacts
1 site in 1 country.
About this study
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 design to demonstrate the safety and performance of the Epitomee Device
Read the 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.
- Conditions
- Overweight, Obesity
- Being tested
- Epitomee Device
- Keywords
- overweight, obesity
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epitomee DeviceDevice
Also called Tulip Device
A non-surgical, non-pharmacologic, medical Device designed to enhance the feeling of satiety.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Epitomee Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluation of the Device administration.
Normal Gastroscopic examination as assessed by an independent safety committee.
Measured: Baseline, 12 weeks
the change in subjects' weight presented as percent total body loss (%TBL)
Subjects loss of weight described as %TBL
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start4 Sep 2014
- Primary completion4 Sep 2018
- Study completion4 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single center, open-labeled single arm study.
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epitomee medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Haim Shirin, MD, Principal investigator, The Kamila Gonczarowski Institute of Gastroenterology Assaf Harofeh Medical Center,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610958
- Sponsor's protocol ID
- PRT-05-022
- Status last verified
- Aug 2021
- First submitted
- 9 Jul 2018
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcomes measures will be made available
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03610958
- Acronym / sponsor ID
- PRT-05-022
- Conditions
- Overweight, Obesity
- Keywords
- overweight, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Epitomee medicalIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2014 (actual)
- Primary completion
- 4 Sep 2018 (actual)
- Study completion
- 4 Sep 2018 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single center, open-labeled single arm study.
| Arm | Type | Receives |
|---|---|---|
| Epitomee Device arm | Experimental | Device: Epitomee DeviceA 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 |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 21 ≤ Age <65 years
- 28 < BMI ≤ 40 kg/m2
- Healthy subject
- Normal blood count and chemistry
- Subject is able and willing to give informed consent
Key exclusion criteria (23 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epitomee DeviceAlso: Tulip DeviceA non-surgical, non-pharmacologic, medical Device designed to enhance the feeling of satiety. | Device | Epitomee Device arm |
Primary outcome
Safety evaluation of the Device administration.
Time frame: Baseline, 12 weeks
Normal Gastroscopic examination as assessed by an independent safety committee.
the change in subjects' weight presented as percent total body loss (%TBL)
Time frame: Baseline, 12 weeks
Subjects loss of weight described as %TBL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcomes measures will be made available
Related trials for Overweight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haim Shirin, MD principal investigator
The Kamila Gonczarowski Institute of Gastroenterology Assaf Harofeh Medical Center,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epitomee Device in people with Overweight and Obesity, run by Epitomee medical at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety evaluation of the Device administration. (time frame: Baseline, 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.