Determination of the Characteristics of Isometric Gastric Motility Measurement in Healthy Volunteers

There is a clear need for a novel method that can readily assess gastric motility in daily clinical practice. Isometric determination of the stomach motility would avoid the use of a large flaccid balloon while still being affordable. The aim of this study was to determine the optimal balloon characteristics that enable to measure motility-induced pressure changes in healthy volunteers.

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Key information

Conditions

Gastroparesis Digestive System Diseases Gastrointestinal Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Leuven

Leuven, Vlaams-Brabant, 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 and younger than 18 years.
They are taking medication.
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

Balloon characteristics

Device

Different size balloon

Primary outcomes

Detection of distal stomach-induced contractions using various intragastric balloons

Time frame: up to 1 year

A comparison of various intragastric balloons for the assessment of gastric motility

Sponsors and collaborators

Lead sponsor

Prof Dr Jan Tack

Other

Registry information

Official study title

ANTERO-AC-2: Determination of the Characteristics of Isometric Gastric Motility Measurement in Healthy Volunteers

Acronym: ANTERO-AC-2

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Feb 22, 2018
Registry last updated: Feb 22, 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.

Published trials that share one or more normalized conditions with this study.

Completed