NCT01844440

Diagnostic of Transient Lower Esophageal Sphincter Relaxation With Combined Impedance and High Resolution Manometry in Patients With GERD

Diagnostic of Transient Lower Esophageal Sphincter Relaxation With Combined Impedance and High Resolution Manometry in Patients With GERD.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to establish and validate High resolution manometry (HRM) criteria for the definition of transient lower esophageal sphincter relaxations (tLESRs) in gastroesophageal reflux disease (GERD) patients.

Detailed description

tLESRs represent the main mechanism of all types of reflux events. Inhibition of transient lower esophageal sphincter relaxations (tLESRs) has become one of the most relevant therapeutic objectives in patients with reflux symptoms resistant to proton pump inhibitors. HRM is the gold standard for detecting and characterizing tLESR, and could be considered as part of the pharmacological evaluation of new drugs targeting tLESRs. HRM criteria for the objective definition of tLESRs in GERD patients have to be established, as it has been done in healthy patients Subjects will undergo impedance / manometry recording with solid-state catheter systems, during a 30-min fasting and a 2-hour postprandial periods.

Conditions

• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
PROCEDURE	High resolution manometry	Subjects will undergo impedance / manometry recording with solid-state catheter systems, during a 30-min fasting and a 2-hour postprandial periods.

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2013-05-01
• Last updated: 2014-07-02

Locations

3 sites across 1 country: France