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Completed

NCT Number: NCT04485936

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

Evaluation of the effect of Epitomee Device on Gastric Emptying Rate in healthy subjects

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Epitomee Device

Device

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

Primary outcomes

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

    Time frame: 10 days

    Change in Gastric half-emptying time

Sponsors and collaborators

Lead sponsor

Epitomee medical

Industry

Registry information

Official study title

Prospective, Single Center, Open-labeled Single Arm Study of Evaluation of the Effect of Tulip Device on Gastric Emptying Rate in Healthy Subjects

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 24, 2020
Registry last updated
Jul 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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