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

February 20, 2018 updated by: Prof Dr Jan Tack

ANTERO-AC-2: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

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
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • University Hospitals Leuven

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 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.

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Circumference of 13 cm, sphere form (diameter of 4 cm)
Device: Balloon characteristics
Different size balloon
Active Comparator: Circumference of 13 cm, cylinder form, length 11 cm
Device: Balloon characteristics
Different size balloon
Active Comparator: Circumference of 16 cm, sphere form (diameter of 5 cm)
Device: Balloon characteristics
Different size balloon
Active Comparator: Circumference of 16 cm, cylinder form, length 11 cm
Device: Balloon characteristics
Different size balloon
Active Comparator: Circumference of 16 cm, cylinder form, length 18 cm
Device: Balloon characteristics
Different size balloon
Active Comparator: Circumference of 19 cm, sphere form (diameter of 6 cm)
Device: Balloon characteristics
Different size balloon
Active Comparator: Circumference of 19 cm, cylinder form, length 11 cm
Device: Balloon characteristics
Different size balloon
Active Comparator: Circumference of 22 cm, sphere form (diameter of 7 cm)
Device: Balloon characteristics
Different size balloon
Active Comparator: Circumference of 25 cm, sphere form (diameter of 8 cm)
Device: Balloon characteristics
Different size balloon
Active Comparator: Circumference of 28 cm, sphere form (diameter of 9 cm)
Device: Balloon characteristics
Different size balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 1 year

Collaborators and Investigators

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

Sponsor

Prof Dr Jan Tack

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)

February 15, 2016

Primary Completion (Actual)

January 20, 2017

Study Completion (Actual)

January 20, 2017

Study Registration Dates

First Submitted

February 2, 2018

First Submitted That Met QC Criteria

February 20, 2018

First Posted (Actual)

February 22, 2018

Study Record Updates

Last Update Posted (Actual)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 20, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S58817

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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