Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
19 participants
INTERVENTIONAL
2018-10-03
2019-04-05
Brief Summary
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Additionally, magnetic resonance imaging will be used to validate an extended 13C-octanoate breath test for gastric emptying of a liquid test meal that is infused over 2 hours. Furthermore, the reliability of a manual position check of the VIPUN Balloon catheter will be confirmed with radiographic imaging. Finally, the data will be used for the data driven optimization of the VIPUN MI algorithm.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Condition A
* Infusion rate = 25 ml/h
* Radiography: confirmation balloon position
* VIPUN Balloon Catheter
* 13C-Octanoate Breath Test o
VIPUN Balloon Catheter
The VIPUN Balloon Catheter is a nasogastric balloon catheter consisting of a standard nasogastric double lumen Sump catheter and a balloon attached to this catheter. Once the catheter is advanced into the stomach, the balloon can be inflated. The inflated balloon dimensions and intraballoon pressure are such that intragastric motility can optimally be assessed without inducing epigastric symptoms.
Condition B
* Infusion rate = 75 ml/h
* Magnetic resonance imaging
* VIPUN Balloon Catheter
* 13C-Octanoate Breath Test
VIPUN Balloon Catheter
The VIPUN Balloon Catheter is a nasogastric balloon catheter consisting of a standard nasogastric double lumen Sump catheter and a balloon attached to this catheter. Once the catheter is advanced into the stomach, the balloon can be inflated. The inflated balloon dimensions and intraballoon pressure are such that intragastric motility can optimally be assessed without inducing epigastric symptoms.
Condition C
* Infusion rate = 250 ml/h
* Magnetic resonance imaging
* VIPUN Balloon Catheter
* 13C-Octanoate Breath Testt
VIPUN Balloon Catheter
The VIPUN Balloon Catheter is a nasogastric balloon catheter consisting of a standard nasogastric double lumen Sump catheter and a balloon attached to this catheter. Once the catheter is advanced into the stomach, the balloon can be inflated. The inflated balloon dimensions and intraballoon pressure are such that intragastric motility can optimally be assessed without inducing epigastric symptoms.
Interventions
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VIPUN Balloon Catheter
The VIPUN Balloon Catheter is a nasogastric balloon catheter consisting of a standard nasogastric double lumen Sump catheter and a balloon attached to this catheter. Once the catheter is advanced into the stomach, the balloon can be inflated. The inflated balloon dimensions and intraballoon pressure are such that intragastric motility can optimally be assessed without inducing epigastric symptoms.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 18 years old
* BMI between and including 18 and 30
* Understand and able to read Dutch
* In good health on the basis of medical history
* Female 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
* 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
* History of heart or vascular diseases like irregular heartbeats, angina or heart attack
* Nasopharyngeal surgery in the last 30 days
* History of thermal or chemical injury to upper respiratory tract or esophagus
* Current esophageal or nasopharyngeal obstruction
* Known coagulopathy
* Known esophageal varices
* Metal or other MRI incompatible implants
* Contra-indications for MR (checked by MR safety questionnaire)
* Pregnancy
* Claustrophobia
* Have a known allergy or intolerance to cow milk, soy, saccharose or any other ingredient of Isosource Standard.
18 Years
ALL
Yes
Sponsors
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Prof Dr Jan Tack
OTHER
Responsible Party
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Prof Dr Jan Tack
Head of Clinic - Gastroenterology / Professor of Medicine / Principal Investigator
Locations
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UZ Leuven
Leuven, Vlaams-Brabant, Belgium
Countries
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Other Identifiers
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S61853
Identifier Type: -
Identifier Source: org_study_id
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