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

NCT04485936 | Completed DMC

• 1 other identifier: PRT-05-030
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Evaluation of Epitomee device on Gastric half-emptying time

  Change in Gastric half-emptying time

  10 days

Study Arms (1)

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

Device: Epitomee Device

Interventions

Epitomee Device DEVICE

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

Epitomee Device

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
• 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:

• 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

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

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: July 24, 2020
• Study Start: April 9, 2018
• Primary Completion: April 9, 2019
• Study Completion: July 9, 2019
• Last Updated: July 24, 2020

Record last verified: 2020-07

Data Sharing

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

Locations

IL (1)