Monitoring Stomach Function With an Intragastric Balloon - a Pilot (ANTERO-AC-1)

April 16, 2018 updated by: Prof Dr Jan Tack

A Pilot Study to Investigate Whether Intragastric Pressure During Food Intake Can be Measured Using an Intragastric Bag in Healthy Volunteers

In this pilot study the investigators test the hypothesis that gastric motility can be measured with an intragastric balloon.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZLeuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 1. Bag inflated so that intrabagpressure increases with 2 mmHg
Device: intragastric bag
OTHER: 2. Bag inflated to ¾ volume of 1
Device: intragastric bag

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
max 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof Dr Jan Tack

Investigators

  • Principal Investigator: Jan Tack, Prof., KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2015

Primary Completion (ACTUAL)

January 1, 2016

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

December 8, 2015

First Submitted That Met QC Criteria

April 16, 2018

First Posted (ACTUAL)

April 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 18, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S58484

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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