Clinical Evaluation of the VIPUN Balloon Catheter 0.1 (ANTERO-1)

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Gastric Emptying; Healthy; Motility Disorder

Treatments: Drug: Placebo; Device: VIPUN Balloon Catheter 0.1 inflated; Device: VIPUN Balloon Catheter 0.1 deflated; Drug: Codeine Phosphate

Study type: Interventional

Funder types: Other

Identifiers

NCT03239821

S60320

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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22 participants in 4 patient groups, including a placebo group

Placebo - deflated balloon

Sham Comparator group

Treatment:

Device: VIPUN Balloon Catheter 0.1 deflated

Drug: Placebo

Placebo - inflated balloon

Placebo Comparator group

Treatment:

Device: VIPUN Balloon Catheter 0.1 inflated

Drug: Placebo

Codeine - delfated balloon

Active Comparator group

Treatment:

Drug: Codeine Phosphate

Device: VIPUN Balloon Catheter 0.1 deflated

Codeine - inflated balloon

Active Comparator group

Treatment:

Device: VIPUN Balloon Catheter 0.1 inflated

Drug: Codeine Phosphate