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

Tracking Information

First Received Date ^ICMJE

September 20, 2005

Last Updated Date

June 4, 2008

Start Date ^ICMJE

September 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00217347 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Condition ^ICMJE

Gastroesophageal Reflux Disease
Dyspepsia

Intervention ^ICMJE

Device: Esophageal Capsule Endoscopy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

150

Completion Date

July 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00217347

Responsible Party

Study ID Numbers ^ICMJE

BRD/05/3-J

Study Sponsor ^ICMJE

Nantes University Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Jean Paul Galmiche, MD

Nantes UH

Information Provided By

Nantes University Hospital

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP