Transient Lower Esophageal Sphincter Relaxations and High Resolution Manometry
|ClinicalTrials.gov Identifier: NCT00931593|
Recruitment Status : Unknown
Verified July 2009 by Hospices Civils de Lyon.
Recruitment status was: Recruiting
First Posted : July 2, 2009
Last Update Posted : July 2, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Device: Esophageal high resolution manometry associated or not with manometry with perfused Dentsleeve probe (as determined by randomization)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transient Lower Esophageal Sphincter Relaxations Detection Using High Resolution Manometry. Validation in Healthy Volunteers.|
|Study Start Date :||May 2009|
|Estimated Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||December 2009|
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):
Visit V1 (day 0):
Visit V2 (day 0 + 1 day): Phone contact
Visit V3 (day 0 + 2 to 7 days):
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00931593
|Contact: ROMAN Sabine, MD||04 72 11 01 email@example.com|
|Hôpital St André, CHU BORDEAUX||Not yet recruiting|
|Bordeaux, France, 33075|
|Contact: ZERBIB Frank, MD 05 56 79 58 06 firstname.lastname@example.org|
|Principal Investigator: ZERBIB Frank, MD|
|Hôpital Edouard Herriot - Hospices Civils de Lyon||Recruiting|
|Lyon, France, 69437|
|Contact: ROMAN Sabine 04 72 11 01 36 email@example.com|
|Principal Investigator: ROMAN Sabine, MD|
|Sub-Investigator: MION François, MD|
|Hôpital Hôtel Dieu, CHU NANTES||Not yet recruiting|
|Nantes, France, 44093|
|Contact: BRULEY DES VARANNES Stanislas, MD 02 40 08 31 65|
|Principal Investigator: BRULEY DE VARANNES Stanislas, MD|
|Principal Investigator:||ROMAN Sabine, MD||Hospices Civils de Lyon|
|Principal Investigator:||MION François, MD||Hospices Civils de Lyon|
|Principal Investigator:||BRULEY DES VARANNES Stanislas, MD||CHRU NANTES|
|Principal Investigator:||ZERBIB Frank, MD||CHRU BORDEAUX|