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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-15

Study Completion Date

2017-01-20

Brief Summary

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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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Detailed Description

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Conditions

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Gastroparesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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

Group Type ACTIVE_COMPARATOR

Balloon characteristics

Intervention Type DEVICE

Different size balloon

Circumference of 13 cm, cylinder form, length 11 cm

Group Type ACTIVE_COMPARATOR

Balloon characteristics

Intervention Type DEVICE

Different size balloon

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

Group Type ACTIVE_COMPARATOR

Balloon characteristics

Intervention Type DEVICE

Different size balloon

Circumference of 16 cm, cylinder form, length 11 cm

Group Type ACTIVE_COMPARATOR

Balloon characteristics

Intervention Type DEVICE

Different size balloon

Circumference of 16 cm, cylinder form, length 18 cm

Group Type ACTIVE_COMPARATOR

Balloon characteristics

Intervention Type DEVICE

Different size balloon

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

Group Type ACTIVE_COMPARATOR

Balloon characteristics

Intervention Type DEVICE

Different size balloon

Circumference of 19 cm, cylinder form, length 11 cm

Group Type ACTIVE_COMPARATOR

Balloon characteristics

Intervention Type DEVICE

Different size balloon

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

Group Type ACTIVE_COMPARATOR

Balloon characteristics

Intervention Type DEVICE

Different size balloon

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

Group Type ACTIVE_COMPARATOR

Balloon characteristics

Intervention Type DEVICE

Different size balloon

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

Group Type ACTIVE_COMPARATOR

Balloon characteristics

Intervention Type DEVICE

Different size balloon

Interventions

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Balloon characteristics

Different size balloon

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes