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

Primary Purpose

Gastroparesis

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Balloon characteristics
Sponsored by
Prof Dr Jan Tack
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastroparesis focused on measuring stomach, motility

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University Hospitals Leuven

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Circumference of 13 cm, sphere form (diameter of 4 cm)

Circumference of 13 cm, cylinder form, length 11 cm

Circumference of 16 cm, sphere form (diameter of 5 cm)

Circumference of 16 cm, cylinder form, length 11 cm

Circumference of 16 cm, cylinder form, length 18 cm

Circumference of 19 cm, sphere form (diameter of 6 cm)

Circumference of 19 cm, cylinder form, length 11 cm

Circumference of 22 cm, sphere form (diameter of 7 cm)

Circumference of 25 cm, sphere form (diameter of 8 cm)

Circumference of 28 cm, sphere form (diameter of 9 cm)

Arm Description

Outcomes

Primary Outcome Measures

Detection of distal stomach-induced contractions using various intragastric balloons
A comparison of various intragastric balloons for the assessment of gastric motility

Secondary Outcome Measures

Full Information

First Posted
February 2, 2018
Last Updated
February 20, 2018
Sponsor
Prof Dr Jan Tack
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1. Study Identification

Unique Protocol Identification Number
NCT03441230
Brief Title
Determination of the Characteristics of Isometric Gastric Motility Measurement in Healthy Volunteers
Acronym
ANTERO-AC-2
Official Title
ANTERO-AC-2: Determination of the Characteristics of Isometric Gastric Motility Measurement in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 15, 2016 (Actual)
Primary Completion Date
January 20, 2017 (Actual)
Study Completion Date
January 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof Dr Jan Tack

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis
Keywords
stomach, motility

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Circumference of 13 cm, sphere form (diameter of 4 cm)
Arm Type
Active Comparator
Arm Title
Circumference of 13 cm, cylinder form, length 11 cm
Arm Type
Active Comparator
Arm Title
Circumference of 16 cm, sphere form (diameter of 5 cm)
Arm Type
Active Comparator
Arm Title
Circumference of 16 cm, cylinder form, length 11 cm
Arm Type
Active Comparator
Arm Title
Circumference of 16 cm, cylinder form, length 18 cm
Arm Type
Active Comparator
Arm Title
Circumference of 19 cm, sphere form (diameter of 6 cm)
Arm Type
Active Comparator
Arm Title
Circumference of 19 cm, cylinder form, length 11 cm
Arm Type
Active Comparator
Arm Title
Circumference of 22 cm, sphere form (diameter of 7 cm)
Arm Type
Active Comparator
Arm Title
Circumference of 25 cm, sphere form (diameter of 8 cm)
Arm Type
Active Comparator
Arm Title
Circumference of 28 cm, sphere form (diameter of 9 cm)
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Balloon characteristics
Intervention Description
Different size balloon
Primary Outcome Measure Information:
Title
Detection of distal stomach-induced contractions using various intragastric balloons
Description
A comparison of various intragastric balloons for the assessment of gastric motility
Time Frame
up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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