Back to resultsMonitoring Stomach Function With an Intragastric Balloon - a Pilot (ANTERO-AC-1)
Primary Purpose
Functional Disorders of Stomach
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
intragastric bag
Sponsored by
About this trial
This is an interventional basic science trial for Functional Disorders of Stomach
Eligibility Criteria
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.
Sites / Locations
- UZLeuven
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
1. Bag inflated so that intrabagpressure increases with 2 mmHg
2. Bag inflated to ¾ volume of 1
Arm Description
Outcomes
Primary Outcome Measures
Intragastric pressure during food intake
The intragastric pressure determined with the manometer and the intragastric bag will be compare before, during and after nutrient drink infusion.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03500887
Brief Title
Monitoring Stomach Function With an Intragastric Balloon - a Pilot
Acronym
ANTERO-AC-1
Official Title
A Pilot Study to Investigate Whether Intragastric Pressure During Food Intake Can be Measured Using an Intragastric Bag in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof Dr Jan Tack
4. Oversight
5. Study Description
Brief Summary
In this pilot study the investigators test the hypothesis that gastric motility can be measured with an intragastric balloon.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Disorders of Stomach
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1. Bag inflated so that intrabagpressure increases with 2 mmHg
Arm Type
Other
Arm Title
2. Bag inflated to ¾ volume of 1
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
intragastric bag
Primary Outcome Measure Information:
Title
Intragastric pressure during food intake
Description
The intragastric pressure determined with the manometer and the intragastric bag will be compare before, during and after nutrient drink infusion.
Time Frame
max 3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Tack, Prof.
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZLeuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Monitoring Stomach Function With an Intragastric Balloon - a Pilot
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