Determination of the Characteristics of Isometric Gastric Motility Measurement in Healthy Volunteers
ANTERO-AC-2
ANTERO-AC-2: Determination of the Characteristics of Isometric Gastric Motility Measurement in Healthy Volunteers
1 other identifier
interventional
8
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2017
CompletedFirst Submitted
Initial submission to the registry
February 2, 2018
CompletedFirst Posted
Study publicly available on registry
February 22, 2018
CompletedFebruary 22, 2018
February 1, 2018
11 months
February 2, 2018
February 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (10)
Circumference of 13 cm, sphere form (diameter of 4 cm)
ACTIVE COMPARATORCircumference of 13 cm, cylinder form, length 11 cm
ACTIVE COMPARATORCircumference of 16 cm, sphere form (diameter of 5 cm)
ACTIVE COMPARATORCircumference of 16 cm, cylinder form, length 11 cm
ACTIVE COMPARATORCircumference of 16 cm, cylinder form, length 18 cm
ACTIVE COMPARATORCircumference of 19 cm, sphere form (diameter of 6 cm)
ACTIVE COMPARATORCircumference of 19 cm, cylinder form, length 11 cm
ACTIVE COMPARATORCircumference of 22 cm, sphere form (diameter of 7 cm)
ACTIVE COMPARATORCircumference of 25 cm, sphere form (diameter of 8 cm)
ACTIVE COMPARATORCircumference of 28 cm, sphere form (diameter of 9 cm)
ACTIVE COMPARATORInterventions
Different size balloon
Eligibility Criteria
You may qualify if:
- They are between 18-60 years old.
- Male and female.
- Patients must provide witnessed written informed consent prior to any study procedures being performed.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Prof Dr Jan Tacklead
Study Sites (1)
University Hospitals Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
February 2, 2018
First Posted
February 22, 2018
Study Start
February 15, 2016
Primary Completion
January 20, 2017
Study Completion
January 20, 2017
Last Updated
February 22, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share