Monitoring Stomach Function With an Intragastric Balloon - a Pilot

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03500887

Acronym

ANTERO-AC-1

Enrollment

Registered

2018-04-18

Start date

2015-11-30

Completion date

2016-02-29

Last updated

2018-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Disorders of Stomach

Brief summary

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

Interventions

DEVICEintragastric bag

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Intragastric pressure during food intake	max 3 hours	The intragastric pressure determined with the manometer and the intragastric bag will be compare before, during and after nutrient drink infusion.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026