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

Prof Dr Jan Tack

Status: Completed

Conditions: Gastroparesis

Treatments: Device: Balloon characteristics

Study type: Interventional

Funder types: Other

Identifiers

NCT03441230

S58817

Details and patient eligibility

About

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.

Enrollment: 8 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 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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8 participants in 10 patient groups

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

Active Comparator group

Treatment:

Device: Balloon characteristics

Circumference of 13 cm, cylinder form, length 11 cm

Active Comparator group

Treatment:

Device: Balloon characteristics

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

Active Comparator group

Treatment:

Device: Balloon characteristics

Circumference of 16 cm, cylinder form, length 11 cm

Active Comparator group

Treatment:

Device: Balloon characteristics

Circumference of 16 cm, cylinder form, length 18 cm

Active Comparator group

Treatment:

Device: Balloon characteristics

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

Active Comparator group

Treatment:

Device: Balloon characteristics

Circumference of 19 cm, cylinder form, length 11 cm

Active Comparator group

Treatment:

Device: Balloon characteristics

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

Active Comparator group

Treatment:

Device: Balloon characteristics

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

Active Comparator group

Treatment:

Device: Balloon characteristics

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

Active Comparator group

Treatment:

Device: Balloon characteristics