Gastroparesis
Conditions
Keywords
stomach, motility
Brief summary
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.
Interventions
DEVICEBalloon characteristics
Different size balloon
Sponsors
Prof Dr Jan Tack
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of distal stomach-induced contractions using various intragastric balloons | up to 1 year | A comparison of various intragastric balloons for the assessment of gastric motility |
Countries
Belgium
Outcome results
None listed