Informations générales (source: ClinicalTrials.gov)
Transient Lower Esophageal Sphincter Relaxations Detection Using High Resolution Manometry. Validation in Healthy Volunteers.
Interventional
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
mai 2009
décembre 2009
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Hôpital Edouard Herriot - Hospices Civils de Lyon - 69437 - Lyon - France | ROMAN Sabine | Contact (sur clinicalTrials) | |||
| Hôpital Hôtel Dieu, CHU NANTES - 44093 - Nantes - France | BRULEY DES VARANNES Stanislas, MD | Contact (sur clinicalTrials) | |||
| Hôpital St André, CHU BORDEAUX - 33075 - Bordeaux - France | ZERBIB Frank, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
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
1. Age under 18 years or upper 60
2. Pregnant woman or lactation
3. Incapability to give consent
4. No written informed consent