The primary aim of this investigation is to assess the safety, feasibility and performance of the VIPUN Balloon Catheter 0.1 in the assessment of gastric motility. The investigation will also assess whether the inflation of the VIPUN Balloon Catheter can stimulate gastric motility and emptying. Furthermore, this investigation will examine whether gastric motility and emptying as measured in this study are correlated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
22
UZ Leuven Gasthuisberg
Leuven, Belgium
Safety: Incidence, frequency, severity, seriousness and relatedness of AEs during the 8 hour visit.
Incidence, frequency, severity, seriousness and relatedness of AEs
Time frame: 8 hours
Feasibility: Success rate in completing the procedure (placement and removal VIPUN Balloon Catheter) during the 8 hour visit.
Success rate in completing the procedure (placement and removal VIPUN Balloon Catheter)
Time frame: 8 hours
Performance: Motility index (MI) decrease after codeine treatment vs. placebo treatment (inflated balloon) during the 8 hour visit.
Motility index (MI) decrease after codeine treatment vs. placebo treatment (inflated balloon)
Time frame: 8 hours
Change in gastric emptying: placebo vs. codeine and deflated vs. inflated balloon
To explore whether the VIPUN Balloon Catheter 0.1 can influence gastric motility and/or emptying.
Time frame: 8 hours
Correlation motility index change and gastric emptying time change: placebo vs. codeine (inflated balloon)
To explore whether there is a correlation between gastric motility and emptying.
Time frame: 8 hours
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VIPUN Balloon Catheter 0.1 inflated