UnknownNot Applicable

Assessment of Normal Values of Esophagogastric Junction (EGJ) Distensibility in Healthy Volunteers

Netherlands15 participantsStarted 2013-11

Plain-language summary

To assess normal values of EGJ distensibility in healthy volunteers.

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. No history of gastrointestinal disease, especially gastro-esophageal reflux disease
✓. BMI = 18-30 kg/m²
✓. Caucasian race
✓. Subject signed the informed consent form and is able to adhere to study protocol

✕. Age \< 18 years
✕. Previous esophageal or gastric surgery
✕. Co-morbidities (including cardiopulmonary disease, collagen diseases, obesity, coagulation disorders and co-morbidity hindering upper gastrointestinal endoscopy)
✕. Patients using anticoagulants
✕. Patients unable to give informed consent
✕. Smoking
✕. History of alcohol abuse or current excessive alcohol consumption (\> 2 alcoholic beverages per day or \> 14 alcoholic beverages per week)

normal values of esophagogastric junction (EGJ) distensibility (mm2/mmHg) in healthy volunteers as measured with the EndoFLIP device

Timeframe: 3 months

NCT IDNCT01956877

SponsorMaastricht University Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2014-08

Fabienne Smeets, MD