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
2 participants
INTERVENTIONAL
2021-04-21
2021-04-30
Brief Summary
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However, the exact relation between individual gastric contractions and individual intraballoon pressure waves remains incompletely understood.
Simultaneous assessment of gastric motility by means of an isovolumetric balloon and dynamic cine-MRI can validate that slow, high-amplitude intraballoon pressure waves are indeed induced by gastric muscle contractions. This evaluation might also enable us to attribute artefacts present in the pressure signal to physiologic processes such as cardiac, respiratory, intestinal and whole-body movements.
To date substantial uncertainty exists on the optimal procedural approach to evaluate gastric motility simultaneously with cine-MRI and the isovolumetric balloon.
The aim of this pilot study is to verify the feasibility of a several aspects of a larger confirmatory study protocol. This includes the evaluation of contrast of the balloon catheter on MRI (this would omit the need for radiographic confirmation), timelines, practical hurdles, analysis procedures and data management.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Combined pressure measurement and MRI
Gastric motility is evaluated simultaneously by means of the investigational medical device and by means of cine-MRI.
VIPUN Gastric Monitoring System prototype
The VIPUN Balloon Catheter prototype is a nasogastric feeding tube with integrated balloon that can be inflated with a preset volume of air. Intraballoon pressure changes are recorded outside the body. Gastric contractions can be detected in the pressure profile.
The recording lasts 30 minutes and is combined with simultaneous cine magnetic resonance imaging.
Interventions
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VIPUN Gastric Monitoring System prototype
The VIPUN Balloon Catheter prototype is a nasogastric feeding tube with integrated balloon that can be inflated with a preset volume of air. Intraballoon pressure changes are recorded outside the body. Gastric contractions can be detected in the pressure profile.
The recording lasts 30 minutes and is combined with simultaneous cine magnetic resonance imaging.
Eligibility Criteria
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Inclusion Criteria
* At least 18 years old
* Male
* BMI between and including 18 and 30
* Understand and able to read Dutch
* In good health on the basis of medical history
Exclusion Criteria
* 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)
* Claustrophobia
18 Years
MALE
Yes
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Locations
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UZ Leuven
Leuven, , Belgium
Countries
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Other Identifiers
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S65104
Identifier Type: -
Identifier Source: org_study_id