Determination of the Characteristics of Isometric Gastric Motility Measurement in Healthy Volunteers

Study Overview
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Brief Summary
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There is a clear need for a novel method that can readily assess gastric motility in daily clinical practice. Isometric determination of the stomach motility would avoid the use of a large flaccid balloon while still being affordable. The aim of this study was to determine the optimal balloon characteristics that enable to measure motility-induced pressure changes in healthy volunteers.

Official Title
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ANTERO-AC-2: Determination of the Characteristics of Isometric Gastric Motility Measurement in Healthy Volunteers

Conditions
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Gastroparesis

Intervention / Treatment
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* Device: Balloon characteristics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: They are between 18-60 years old. Male and female. Patients must provide witnessed written informed consent prior to any study procedures being performed. Exclusion Criteria: They are older than 60 years old and younger than 18 years. They are taking medication. Have severely decreased kidney function. Have severely decreased liver function. Have severe heart disease, for example a history of irregular heartbeats, angina or heart attack. Have severe lung disease. Have severe psychiatric illness or neurological illness. Have any gastrointestinal disease. Have any dyspeptic symptoms. Women that are pregnant or breastfeeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Circumference of 13 cm, sphere form (diameter of 4 cm)<br> | Device: Balloon characteristics<br>* Different size balloon<br>|
| Active Comparator: Circumference of 13 cm, cylinder form, length 11 cm<br> | Device: Balloon characteristics<br>* Different size balloon<br>|
| Active Comparator: Circumference of 16 cm, sphere form (diameter of 5 cm)<br> | Device: Balloon characteristics<br>* Different size balloon<br>|
| Active Comparator: Circumference of 16 cm, cylinder form, length 11 cm<br> | Device: Balloon characteristics<br>* Different size balloon<br>|
| Active Comparator: Circumference of 16 cm, cylinder form, length 18 cm<br> | Device: Balloon characteristics<br>* Different size balloon<br>|
| Active Comparator: Circumference of 19 cm, sphere form (diameter of 6 cm)<br> | Device: Balloon characteristics<br>* Different size balloon<br>|
| Active Comparator: Circumference of 19 cm, cylinder form, length 11 cm<br> | Device: Balloon characteristics<br>* Different size balloon<br>|
| Active Comparator: Circumference of 22 cm, sphere form (diameter of 7 cm)<br> | Device: Balloon characteristics<br>* Different size balloon<br>|
| Active Comparator: Circumference of 25 cm, sphere form (diameter of 8 cm)<br> | Device: Balloon characteristics<br>* Different size balloon<br>|
| Active Comparator: Circumference of 28 cm, sphere form (diameter of 9 cm)<br> | Device: Balloon characteristics<br>* Different size balloon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of distal stomach-induced contractions using various intragastric balloons | A comparison of various intragastric balloons for the assessment of gastric motility | up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stomach, motility