Assessment of normal values of Esophagogastric Junction (EGJ) distensibility in healthy volunteers

Completed

• Conditions: EGJ compliance; esophagogastric junction (EGJ) distensibility; 10017977

• Registration Number: NL-OMON38531
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

1. No history of gastrointestinal disease, specially GERD
2. BMI = 18-30 kg/m²
3. Caucasian race
4. Subject signed the informed consent form and is able to adhere to study protocol

Exclusion Criteria

age < 18 years and > 65 years, co-morbidities (cardiopulmonary disease, collagen diseases, obesity, coagulation disorders and co-morbidity hindering a gastroscopic procedure), previous oesophageal or gastric surgery, 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)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is to assess normal values of EGJ<br /><br>distensibility in healthy volunteers.<br /><br>Endpoint: EGJ distensibility as assessed with the EndoFLIP system</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>This study has no secondary objectives/endpoints. </p><br>