Status:
COMPLETED
Clinical Evaluation of the VIPUN Balloon Catheter 0.1
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Healthy
Motility Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2018
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03239821
Start Date
September 25 2017
End Date
April 30 2018
Last Update
May 4 2018
Active Locations (1)
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1
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000