An interventional study of Esophageal high resolution manometry associated or not with manometry with perfused Dentsleeve probe (as determined by randomization) in Healthy Volunteers, sponsored by Hospices Civils de Lyon. Status unknown at 3 sites in France. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-07-02.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Diagnostic
Transient lower esophageal sphincter relaxations (tLESr) are the main mechanism of gastro-oesophageal reflux disease. They occur without any deglutition in patients but also in healthy volunteers. They are induced by meal.
The gold standard to detect tLESr is esophageal manometry using perfused Dentsleeve probe.
Esophageal high resolution manometry with solid state sensors was developed in the 90s. The examination is easier and more accurate than perfused manometry. The aim of this study is to validate in healthy volunteers the use of high resolution manometry (Sierra Scientific Instruments, California CA) to detect tLESr.
Hospices Civils de Lyon is the lead sponsor of 1,856 studies on the registry; 442 are open to participants now.
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This is a descriptive study to compare two techniques (manometry with perfused dentsleeve probe vs high resolution manometry for the identification of tLESr). Each subject is his own control. The date of perfused manometry is randomized to avoid bias due to examinations' order.
Device: Esophageal high resolution manometry associated or not with manometry with perfused Dentsleeve probe (as determined by randomization)
Visit V0 (day 0 - 2 to 14 days): * Subject selection * Obtaining of written informed consent Visit V1 (day 0): * Fasting subject * Randomization to determine the examination order * Esophageal high resolution manometry (Sierra Scientific Instruments, California CA) associated or not with manometry with perfused Dentsleeve probe (as determined by randomisation): 3-hour recording (1 hour fasting, ingestion of a 600-kcal liquid meal in 10 minutes, 2 hours post prandial) Visit V2 (day 0 + 1 day): Phone contact Visit V3 (day 0 + 2 to 7 days): * Same as V1 Visit V4 (V3 + 1 day): Phone contact and end of the study
The primary outcome is to demonstrate that high resolution manometry allows the detection of meal-induced tLESr. All recordings will be analyzed at the end of each examination and reviewed at the end of the enrolment.
To compare the number of tLESr detected by high resolution manometry and those detected by manometry with perfused dentsleeve probe.
To define the characteristics (duration, relaxation amplitude) of high resolution manometry-detected tLESr.
The record gives a start of May 2009, a primary completion of Dec 2009 and a completion of Dec 2009. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
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