Transient Lower Esophageal Sphincter Relaxations and High Resolution Manometry
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Hospices Civils de Lyon.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Hospices Civils de Lyon
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00931593
First received: July 1, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
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Purpose
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 | Intervention |
|---|---|
|
Healthy Volunteers |
Device: Esophageal high resolution manometry associated or not with manometry with perfused Dentsleeve probe (as determined by randomization) |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Transient Lower Esophageal Sphincter Relaxations Detection Using High Resolution Manometry. Validation in Healthy Volunteers. |
Resource links provided by NLM:
Further study details as provided by Hospices Civils de Lyon:
Primary Outcome Measures:
- 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. [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To compare the number of tLESr detected by high resolution manometry and those detected by manometry with perfused dentsleeve probe. [ Designated as safety issue: No ]
- To define the characteristics (duration, relaxation amplitude) of high resolution manometry-detected tLESr. [ Designated as safety issue: No ]
| Estimated Enrollment: | 24 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: volunteers
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 |
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Male or Female between 18 and 60 years
- Subject without typical or atypical symptoms of gastro-esophageal reflux disease (heartburn, regurgitation, epigastric pain, chest pain, chronic cough, pharyngeal pain)
- Subject without any medication (except oral contraception)
- Subject without previous digestive surgery history (except appendicectomy)
- Capability to pass manometric probes through each nostril
- Subject with health insurance
- Written informed consent
- No participation to another study at the same time
Exclusion Criteria:
- Age under 18 years or upper 60
- Pregnant woman or lactation
- Incapability to give consent
- No written informed consent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00931593
Contacts
| Contact: ROMAN Sabine, MD | 04 72 11 01 36 | sabine.roman@chu-lyon.fr |
Locations
| France | |
| Hôpital St André, CHU BORDEAUX | Not yet recruiting |
| Bordeaux, France, 33075 | |
| Contact: ZERBIB Frank, MD 05 56 79 58 06 frank.zerbib@chu-bordeaux.fr | |
| Principal Investigator: ZERBIB Frank, MD | |
| Hôpital Edouard Herriot - Hospices Civils de Lyon | Recruiting |
| Lyon, France, 69437 | |
| Contact: ROMAN Sabine 04 72 11 01 36 sabine.roman@chu-lyon.fr | |
| 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 | |
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Dr Sabine ROMAN, Hospices Civils de Lyon |
| ClinicalTrials.gov Identifier: | NCT00931593 History of Changes |
| Other Study ID Numbers: | 2008.546/47 |
| Study First Received: | July 1, 2009 |
| Last Updated: | July 1, 2009 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Hospices Civils de Lyon:
|
Transient lower esophageal sphincter relaxation high resolution manometry dentsleeve probe healthy volunteers |
Additional relevant MeSH terms:
|
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013