NCT00217347

Evaluation of Efficiency of Esophageal Capsule Endoscopy in the Screening of Patients With Gastroesophageal Reflux Disease or Dyspepsia as Compared to Upper Endoscopy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The exploration of evocative symptoms of esophageal reflux disease or dyspepsia is based on a relatively invasive endoscopic examination, often badly tolerated, and which, in France, is carried out in 50% of the cases under general anaesthesia. The development of a Capsule Endoscopy, of single use, of esophageal exploration (PILLCAM OESO), could allow a painless exploration of the oesophagus, without infectious risk.The aim of this study is to validate the information provided by the Esophageal Capsule Endoscopy compared to upper endoscopy in the screening of patients with gastroesophageal reflux disease or dyspepsia . For that these patients, after being informed and to have given their signed assent, will initially have an exploration by Esophageal Capsule Endoscopy and then, the very same day or within 3 days maximum, a upper endoscopy'. The information provided by the Esophageal Capsule Endoscopy then by the upper endoscopy will be analyzed by investigators different. This study should make it possible to evaluate the parameters of specificity, sensitivity and predictive values of Esophageal Capsule Endoscopy in this indication.

Conditions

• Gastroesophageal Reflux Disease
• Dyspepsia

Interventions

Type	Name	Description
DEVICE	Esophageal Capsule Endoscopy

Timeline

• Start date: 2005-09-01
• Completion: 2006-07-01
• First posted: 2005-09-22
• Last updated: 2008-06-05

Locations

1 site across 1 country: France