Transient Lower Esophageal Sphincter Relaxations and High Resolution Manometry

Healthy Volunteers Clinical Trial

Official title:

Transient Lower Esophageal Sphincter Relaxations Detection Using High Resolution Manometry. Validation in Healthy Volunteers.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00931593
• Other study ID #: 2008.546/47
• Status: Recruiting
• Phase: N/A
• First received: July 1, 2009
• Last updated: July 1, 2009
• Start date: May 2009
• Est. completion date: December 2009

Study information

• Verified date: July 2009
• Source: Hospices Civils de Lyon
• Contact: ROMAN Sabine, MD
• Phone: 04 72 11 01 36
• Email: sabine.roman[@]chu-lyon.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Male or Female between 18 and 60 years

2. Subject without typical or atypical symptoms of gastro-esophageal reflux disease (heartburn, regurgitation, epigastric pain, chest pain, chronic cough, pharyngeal pain)

3. Subject without any medication (except oral contraception)

4. Subject without previous digestive surgery history (except appendicectomy)

5. Capability to pass manometric probes through each nostril

6. Subject with health insurance

7. Written informed consent

8. No participation to another study at the same time

Exclusion Criteria:

1. Age under 18 years or upper 60

2. Pregnant woman or lactation

3. Incapability to give consent

4. No written informed consent

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
France	Hôpital St André, CHU BORDEAUX	Bordeaux
France	Hôpital Edouard Herriot - Hospices Civils de Lyon	Lyon
France	Hôpital Hôtel Dieu, CHU NANTES	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.			No
Secondary	To compare the number of tLESr detected by high resolution manometry and those detected by manometry with perfused dentsleeve probe.			No
Secondary	To define the characteristics (duration, relaxation amplitude) of high resolution manometry-detected tLESr.			No