Monitoring Stomach Function With an Intragastric Balloon - a Pilot

Not Applicable

Completed

• Conditions: Functional Disorders of Stomach
• Interventions: Device: intragastric bag

• Registration Number: NCT03500887
• Lead Sponsor: Prof Dr Jan Tack

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-12-08
• Primary Completion: 2016-01
• Study Completion: 2016-02
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-16
• Last Update Submitted: 2018-04-16
• Study First Posted: 2018-04-18
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2. Bag inflated to ¾ volume of 1	intragastric bag	-
1. Bag inflated so that intrabagpressure increases with 2 mmHg	intragastric bag	-

Primary Outcome Measures

Name	Time	Method
Intragastric pressure during food intake	max 3 hours	The intragastric pressure determined with the manometer and the intragastric bag will be compare before, during and after nutrient drink infusion.

Trial Locations

Locations (1)

UZLeuven; 🇧🇪 Leuven, Belgium