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

NCT ID: NCT00217347

Last Updated: 2008-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2006-07-31

Brief 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

Keywords

Gastroesophageal reflux; Dyspepsia; Esophageal Capsule Endoscopy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Esophageal Capsule Endoscopy

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient age is 18 years or older
• Patient Suffers from gastroesophageal reflux disease or dyspepsia, did not undergo previous upper endoscopy, with clinical indication to upper endoscopy,able to tolerate an upper endoscopy without general anesthesia
• Patient agrees and signs the Informed Consent Form

Exclusion Criteria

• Dysphagia
• Known Zenker's Diverticulum
• Known or suspected intestinal obstruction.
• Cardiac pacemakers or other implanted electro medical devices.
• Female pregnant patient
• Upper Endoscopy for control or recent upper endoscopy
• Chronic alcoholism defined by a daily consumption of alcohol over 80 g
• Severe hepatopathy
• Severe, primitive or secondary gastroparesis
• Known cancer
• Abnormalities of coagulation
• Incapacity to understand and sign a sensible consent of participation to the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Jean Paul Galmiche, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes UH

Locations

Nantes University Hospital

Nantes, , France

Countries

France

Other Identifiers

BRD/05/3-J

Identifier Type: -

Identifier Source: org_study_id