Clinical Evaluation of the VIPUN Balloon Catheter 0.1

Study Overview
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Brief Summary
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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.

Official Title
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ANTERO-1: a Clinical Evaluation of an Investigational Device: the VIPUN Balloon Catheter 0.1 Used for the Evaluation of Gastric Motility

Conditions
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Healthy, Motility Disorder, Gastric Emptying

Intervention / Treatment
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* Device: VIPUN Balloon Catheter 0.1 deflated
* Drug: Codeine Phosphate
* Drug: Placebo
* Device: VIPUN Balloon Catheter 0.1 inflated


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Informed Consent Aged between and including 18 and 65 years BMI between and including 18 and 25 Understand and able to read Dutch In good health on the basis of medical history Able to return home without driving a vehicle on visit days 1-4 Will not operate machines on the same day of treatment (visits 1-4) Females subjects of childbearing potential are willing to use adequate contraception Refrains from herbal, vitamin and other dietary supplements on the day of the visits Exclusion Criteria: Exclusion criteria related to possible influence on end-points: Dyspeptic symptoms (assessed with PAGI-SYM questionnaire) Using any medication that might affect gastric function or visceral sensitivity Known / suspected current use of illicit drugs Known psychiatric or neurological illness Any gastrointestinal surgery that could influence normal gastric function in the opinion of the investigator Exclusion criteria related to positioning of the catheter: History of heart or vascular diseases like irregular heartbeats, angina or heart attack Nasopharyngeal, upper GI or esophageal surgery in the last 30 days Suspected basal skull fracture or severe maxillofacial trauma History of thermal or chemical injury to upper respiratory tract or esophagus Current esophageal or nasopharyngeal obstruction Known coagulopathy Known esophageal varices Exclusion criteria related to codeine administration: History of opioid dependency Known severely decreased kidney or liver function Pregnant or breastfeeding women (pregnancy test will be performed on females with childbearing potential) Known severe lung disease (e.g. asthma or emphysema) Have known side-effects/allergic reactions when taking codeine/morphine Known diabetic, fructose intolerance or malabsorption of glucose or galactose or sucrose-isomalase insufficiency. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Interventional Model Description: A single-blinded, monocenter, randomized crossover investigation in healthy volunteers.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Placebo - deflated balloon<br> | Device: VIPUN Balloon Catheter 0.1 deflated<br>* deflation balloon<br>Drug: Placebo<br>* Sirupus Simplex<br>|
| Placebo Comparator: Placebo - inflated balloon<br> | Drug: Placebo<br>* Sirupus Simplex<br>Device: VIPUN Balloon Catheter 0.1 inflated<br>* VIPUN Balloon Catheter 0.1 inflated<br>|
| Active Comparator: Codeine - delfated balloon<br> | Device: VIPUN Balloon Catheter 0.1 deflated<br>* deflation balloon<br>Drug: Codeine Phosphate<br>* 58.8 mg codeïne phosphate<br>|
| Active Comparator: Codeine - inflated balloon<br> | Drug: Codeine Phosphate<br>* 58.8 mg codeïne phosphate<br>Device: VIPUN Balloon Catheter 0.1 inflated<br>* VIPUN Balloon Catheter 0.1 inflated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | To explore whether there is a correlation between gastric motility and emptying. | 8 hours |