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

P

Prof Dr Jan Tack

Status

Completed

Conditions

Gastroparesis

Treatments

Device: Balloon characteristics

Study type

Interventional

Funder types

Other

Identifiers

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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