Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo - deflated balloon | Sham Comparator |
| |
| Placebo - inflated balloon | Placebo Comparator |
| |
| Codeine - delfated balloon | Active Comparator |
| |
| Codeine - inflated balloon | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIPUN Balloon Catheter 0.1 deflated | Device | deflation balloon |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence, frequency, severity, seriousness and relatedness of AEs during the 8 hour visit. | Incidence, frequency, severity, seriousness and relatedness of AEs | 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) | 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) | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 hours |
| Correlation motility index change and gastric emptying time change: placebo vs. codeine (inflated balloon) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria related to possible influence on end-points:
Exclusion criteria related to positioning of the catheter:
Exclusion criteria related to codeine administration:
Exclusion criteria related to Sirupus simplex administration:
• Known diabetic (saccharose), intolerance to or malabsorption of propylene glycol and methyl- and propylparahydroxybenzoate
Exclusion criteria related to nutrients (Fortimel):
• Have a known allergy or intolerance to cow milk, soy, saccharose or any other ingredient of Fortimel Energy
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
Not provided
| ID | Term |
|---|---|
| D003061 | Codeine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
Not provided
Not provided
A single-blinded, monocenter, randomized crossover investigation in healthy volunteers.
Not provided
Not provided
Not provided
| Codeine Phosphate | Drug | 58.8 mg codeïne phosphate |
|
| Placebo | Drug | Sirupus Simplex |
|
| VIPUN Balloon Catheter 0.1 inflated | Device | VIPUN Balloon Catheter 0.1 inflated |
|
To explore whether there is a correlation between gastric motility and emptying. |
| 8 hours |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |