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

Gastroparesis Clinical Trial

— ANTERO-AC-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03441230
• Other study ID #: S58817
• Status: Completed
• Phase: N/A
• First received: February 2, 2018
• Last updated: February 20, 2018
• Start date: February 15, 2016
• Est. completion date: January 20, 2017

Study information

• Verified date: February 2018
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 20, 2017
• Est. primary completion date: January 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Device:
• Balloon characteristics
Different size balloon

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Prof Dr Jan Tack

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of distal stomach-induced contractions using various intragastric balloons	A comparison of various intragastric balloons for the assessment of gastric motility	up to 1 year