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

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ClinicalTrials.gov Identifier: NCT01956877
Recruitment Status : Unknown
Verified August 2014 by Maastricht University Medical Center.
Recruitment status was:  Recruiting
First Posted : October 8, 2013
Last Update Posted : August 5, 2014
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:
To assess normal values of EGJ distensibility in healthy volunteers.

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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Normal Values of Esophagogastric Junction (EGJ) Distensibility in Healthy Volunteers
Study Start Date : November 2013
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : August 2014

Group/Cohort
Healthy volunteers



Primary Outcome Measures :
  1. normal values of esophagogastric junction (EGJ) distensibility (mm2/mmHg) in healthy volunteers as measured with the EndoFLIP device [ Time Frame: 3 months ]
    EGJ distensibility as measured by the index of the narrowest cross sectional area (mm2) and the corresponding intrabag pressure (mmHg)


Secondary Outcome Measures :
  1. Establishing a cut-off value of EGJ distensibility (mm2/mmHg) based on the 90% percentile distribution of measurements performed in healthy volunteers. [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
15 healthy volunteers, age > years
Criteria

Inclusion Criteria:

  1. No history of gastrointestinal disease, especially gastro-esophageal reflux disease
  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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956877


Contacts
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Contact: Fabienne Smeets, MD +31433875021 FGM.Smeets@student.maastrichtuniversity.nl
Contact: José M Conchillo, MD PhD +31433875021 j.conchillo@mumc.nl

Locations
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Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Netherlands, 6229 HX
Contact: Fabienne Smeets, MD    +3143-3875021    FGM.Smeets@student.maastrichtuniversity.nl   
Principal Investigator: José M Conchillo, MD PhD         
Sponsors and Collaborators
Maastricht University Medical Center

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01956877     History of Changes
Other Study ID Numbers: NL45176.068.13
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: August 5, 2014
Last Verified: August 2014