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

Sponsor

Nantes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00217347

Collaborator

(none)

150

Enrollment

Location

Duration (Months)

15.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Disease Dyspepsia	Device: Esophageal Capsule Endoscopy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Study Start Date :

Sep 1, 2005

Actual Study Completion Date :

Jul 1, 2006

Outcome Measures

Primary Outcome Measures

To determine the parameters of sensitivity, specificity, positive and negative predictive values of the Esophageal Capsule Endoscopy []

Secondary Outcome Measures

To compare Esophageal Capsule Endoscopy and upper endoscopy in detection and classification of esophagitis. []
To determine the inter-observer agreement for the classification of esophagitis. []
To compare Esophageal Capsule Endoscopy and upper endoscopy in detection of stomachal or duodenal lesions. []
To evaluate the tolerance of the two examinations []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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