Status:
COMPLETED
Evaluation of the Effect of Epitomee Device on Gastric Emptying Rate in Healthy Subjects
Lead Sponsor:
Epitomee medical
Conditions:
Overweight and Obesity
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
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). F...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04485936
Start Date
April 9 2018
End Date
July 9 2019
Last Update
July 24 2020
Active Locations (1)
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1
Assaf Harofeh Medical Center
Ẕerifin, Israel, 70300