NCT03500887CompletedNot Applicable
A Pilot Study to Investigate Whether Intragastric Pressure During Food Intake Can be Measured Using an Intragastric Bag in Healthy Volunteers
Prof Dr Jan Tack1 site in 1 country6 target enrollmentStarted: November 1, 2015Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Intragastric pressure during food intake
Study Overview
Brief Summary
In this pilot study the investigators test the hypothesis that gastric motility can be measured with an intragastric balloon.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •They are between 18-60 years old.
- •Male and female.
- •Patients must provide witnessed written informed consent prior to any study procedures being performed.
Exclusion Criteria
- •They are older than 60 years old.
- •Have severely decreased kidney function.
- •Have severely decreased liver function.
- •Have severe heart disease, for example a history of irregular heartbeats, angina or heart attack.
- •Have severe lung disease.
- •Have severe psychiatric illness or neurological illness.
- •Have any gastrointestinal disease.
- •Have any dyspeptic symptoms.
- •Women that are pregnant or breastfeeding.
Arms & Interventions
1. Bag inflated so that intrabagpressure increases with 2 mmHg
Other
Intervention: intragastric bag (Device)
2. Bag inflated to ¾ volume of 1
Other
Intervention: intragastric bag (Device)
Outcomes
Primary Outcomes
Intragastric pressure during food intake
Time Frame: max 3 hours
The intragastric pressure determined with the manometer and the intragastric bag will be compare before, during and after nutrient drink infusion.
Secondary Outcomes
No secondary outcomes reported
Investigators
Prof Dr Jan Tack
Prof.
Universitaire Ziekenhuizen KU Leuven
Study Sites (1)
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