Monitoring Stomach Function With an Intragastric Balloon - a Pilot (ANTERO-AC-1)

Prof Dr Jan Tack

Status: Completed

Conditions: Functional Disorders of Stomach

Treatments: Device: intragastric bag

Study type: Interventional

Funder types: Other

Identifiers

NCT03500887

S58484

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts 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.
• 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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6 participants in 2 patient groups

1. Bag inflated so that intrabagpressure increases with 2 mmHg

Other group

Treatment:

Device: intragastric bag

2. Bag inflated to ¾ volume of 1

Other group

Treatment:

Device: intragastric bag