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CompletedNCT04485936Updated Jul 24, 2020

Evaluation of the Effect of Epitomee Device on Gastric Emptying Rate in Healthy Subjects

An interventional study of Epitomee Device in Overweight and Obesity, sponsored by Epitomee medical. Completed at 1 site in Israel. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-24.

Sponsored by Epitomee medical · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Apr 2018, registered Jul 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
21 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Overweight and Obesity

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03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 10 is below the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Epitomee medical is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 21 ≤ Age \<65 years
  2. 20 \< BMI ≤ 40 kg/m2
  3. Healthy subject
  4. Subject is able and willing to give informed consent
  5. Subject is able and willing to participate in the study and follow protocol procedures

Exclusion criteria

Exclusion Criteria:

  1. Significant swallowing disorders or difficulty swallowing
  2. Suspected GI strictures, fistulas or other GI track obstructions
  3. Crohn's disease or diverticulosis
  4. Recent GI surgery
  5. History of long-standing undigested food in the stomach
  6. Known ulcer disease
  7. Organic disease associated with gastroparesis such a Parkinson's disease, cerebrovascular accident, neuromuscular disease or eating disorder
  8. Presence of a gastrostomy tube or gastric outlet obstruction
  9. History or evidence of any active liver disease
  10. Allergy to eggs
  11. Treatment with anticholinergic or prokinetic agents
  12. Treatment with proton-pump inhibitors
  13. Hypothyroidism, hyperthyroidism or taking thyroid hormone deficiency drugs (such as L-thyroxine)
  14. Prediabetes or Diabetes
  15. 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
  16. Pregnancy or breastfeeding
  17. Currently participating in an ongoing clinical study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Epitomee Device

    the participants receive the device which is non-surgical, non-pharmacologic, medical Device designed to enhance the feeling of early satiation and prolonged satiety

    Device: Epitomee Device

Interventions

  • DeviceEpitomee Device

    medical Device designed to enhance the feeling of early satiation and prolonged satiety

06

What researchers measure

Primary outcomes

  1. Evaluation of Epitomee device on Gastric half-emptying time

    Change in Gastric half-emptying time

    Time frame: 10 days

07

Study locations

1 site
  • Assaf Harofeh Medical Center
    Zerifin, 70300, Israel
08

References and documents

Individual participant data

Plan to share: Yes — De-identified individual participants data for all primary and secondary outcome measures will be made available

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04485936
Lead sponsor
Epitomee medical
Responsible party
Sponsor
First posted
Jul 24, 2020
Start date
Apr 9, 2018
Primary completion
Apr 9, 2019
Completion
Jul 9, 2019
Last update
Jul 24, 2020

Study contacts

Haim Shirin, MD
principal investigator · The Kamila Gonczarowski Institute of Gastroenterology Assaf Harofeh Medical Center,

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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