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Transient Lower Esophageal Sphincter Relaxations and High Resolution Manometry

NCT00931593 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2009-07-02

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

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

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • ROMAN Sabine, MD · Hospices Civils de Lyon

  • MION François, MD · Hospices Civils de Lyon

  • BRULEY DES VARANNES Stanislas, MD · CHRU NANTES

  • ZERBIB Frank, MD · CHRU BORDEAUX

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00931593 on ClinicalTrials.gov