Monitoring Stomach Function With an Intragastric Balloon

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

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-02-29

Brief Summary

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In this pilot study the investigators test the hypothesis that gastric motility can be measured with an intragastric balloon.

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Detailed Description

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Conditions

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Functional Disorders of Stomach

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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1. Bag inflated so that intrabagpressure increases with 2 mmHg

Group Type OTHER

intragastric bag

Intervention Type DEVICE

2. Bag inflated to ¾ volume of 1

Group Type OTHER

intragastric bag

Intervention Type DEVICE

Interventions

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intragastric bag

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.
* 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