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OpenTrials
Completed

NCT Number: NCT03500887

Monitoring Stomach Function With an Intragastric Balloon - a Pilot

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

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Key information

Conditions

Functional Disorders of Stomach

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZLeuven

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

intragastric bag

Device

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Prof Dr Jan Tack

Other

Registry information

Official study title

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

Acronym: ANTERO-AC-1

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 18, 2018
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.