Overweight and ObesityNCT04485936
Evaluation of the Effect of Epitomee Device on Gastric Emptying Rate in Healthy Subjects
A study testing Epitomee Device in people with Overweight and Obesity, run by Epitomee medical at 1 site in Israel.
Trial summary
Evaluation of the effect of Epitomee Device on Gastric Emptying Rate in healthy subjects Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Epitomee Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 9 Apr 2018to 9 Jul 2019
- 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
- 20 < BMI ≤ 40 kg/m2
- Healthy subject
- 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
- Significant swallowing disorders or difficulty swallowing
- Suspected GI strictures, fistulas or other GI track obstructions
- Crohn's disease or diverticulosis
- Recent GI surgery
- History of long-standing undigested food in the stomach
- Known ulcer disease
Show all 17Show fewer
- Organic disease associated with gastroparesis such a Parkinson's disease, cerebrovascular accident, neuromuscular disease or eating disorder
- Presence of a gastrostomy tube or gastric outlet obstruction
- History or evidence of any active liver disease
- Allergy to eggs
- Treatment with anticholinergic or prokinetic agents
- Treatment with proton-pump inhibitors
- Hypothyroidism, hyperthyroidism or taking thyroid hormone deficiency drugs (such as L-thyroxine)
- Prediabetes or Diabetes
- 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
- Pregnancy or breastfeeding
- 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 of Evaluation of the Effect of Tulip Device on Gastric Emptying Rate in Healthy Subjects
Evaluation of the effect of Epitomee Device on Gastric Emptying Rate in healthy subjects
Read the detailed description
The participants will be enrolled in one investigational site. Subjects meeting eligibility criteria will undergo a gastric emptying test using gastric scintigraphy before any treatment (baseline).
Following the scintigraphy, the subjects will receive Tulip Device treatment - 2 capsules/day.
After repeated capsule intake for either 4 or 11 or 28 days, the subjects will undergo additional gastric emptying test with a capsule intake prior to the test meal.
- Conditions
- Overweight and Obesity
- Being tested
- Epitomee Device
- 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
medical Device designed to enhance the feeling of early satiation and prolonged satiety
| Study group | Role | What they receive |
|---|---|---|
| Epitomee Device | Experimental | the participants receive the device which is non-surgical, non-pharmacologic, medical Device designed to enhance the feeling of early satiation and prolonged satiety Receives: Device: Epitomee Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Epitomee device on Gastric half-emptying time
Change in Gastric half-emptying time
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start9 Apr 2018
- Primary completion9 Apr 2019
- Study completion9 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies 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
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT04485936
- Sponsor's protocol ID
- PRT-05-030
- Status last verified
- Jul 2020
- First submitted
- 9 Jul 2018
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participants data for all primary and secondary outcome measures will be made available
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single Center, Open-labeled Single Arm Study of Evaluation of the Effect of Tulip Device on Gastric Emptying Rate in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04485936
- Acronym / sponsor ID
- PRT-05-030
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Epitomee medicalIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 9 Apr 2019 (actual)
- Study completion
- 9 Jul 2019 (actual)
- First posted
- 24 Jul 2020 (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.
Evaluation of the effect of Epitomee Device on Gastric Emptying Rate in healthy subjects
Detailed description
The participants will be enrolled in one investigational site. Subjects meeting eligibility criteria will undergo a gastric emptying test using gastric scintigraphy before any treatment (baseline).
Following the scintigraphy, the subjects will receive Tulip Device treatment - 2 capsules/day.
After repeated capsule intake for either 4 or 11 or 28 days, the subjects will undergo additional gastric emptying test with a capsule intake prior to the test meal.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epitomee Device | Experimental | Device: Epitomee Devicethe participants receive the device which is non-surgical, non-pharmacologic, medical Device designed to enhance the feeling of early satiation and prolonged satiety |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 21 ≤ Age <65 years
- 20 < BMI ≤ 40 kg/m2
- Healthy subject
- Subject is able and willing to give informed consent
- Subject is able and willing to participate in the study and follow protocol procedures
Key exclusion criteria (17 listed)
- Significant swallowing disorders or difficulty swallowing
- Suspected GI strictures, fistulas or other GI track obstructions
- Crohn's disease or diverticulosis
- Recent GI surgery
- History of long-standing undigested food in the stomach
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 Devicemedical Device designed to enhance the feeling of early satiation and prolonged satiety | Device | Epitomee Device |
Primary outcome
Evaluation of Epitomee device on Gastric half-emptying time
Time frame: 10 days
Change in Gastric half-emptying time
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 24 Jul 2020.
- Individual participant dataSharing planned: Yes. De-identified individual participants data for all primary and secondary outcome measures will be made available
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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 5 inclusion and 17 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 24 Jul 2020. 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?
Evaluation of Epitomee device on Gastric half-emptying time (time frame: 10 days). 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 24 Jul 2020.