Determination of the Characteristics of Isometric Gastric Motility Measurement in Healthy Volunteers
Not Applicable
Completed
- Conditions
- Gastroparesis
- Interventions
- Device: Balloon characteristics
- Registration Number
- NCT03441230
- Lead Sponsor
- Prof Dr Jan Tack
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Circumference of 16 cm, sphere form (diameter of 5 cm) Balloon characteristics - Circumference of 13 cm, sphere form (diameter of 4 cm) Balloon characteristics - Circumference of 16 cm, cylinder form, length 18 cm Balloon characteristics - Circumference of 19 cm, sphere form (diameter of 6 cm) Balloon characteristics - Circumference of 25 cm, sphere form (diameter of 8 cm) Balloon characteristics - Circumference of 13 cm, cylinder form, length 11 cm Balloon characteristics - Circumference of 19 cm, cylinder form, length 11 cm Balloon characteristics - Circumference of 22 cm, sphere form (diameter of 7 cm) Balloon characteristics - Circumference of 16 cm, cylinder form, length 11 cm Balloon characteristics - Circumference of 28 cm, sphere form (diameter of 9 cm) Balloon characteristics -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospitals Leuven
🇧🇪Leuven, Vlaams-Brabant, Belgium