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

Sponsor:	Nantes University Hospital
Information provided by:	Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT00217347

Purpose

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	Intervention
Gastroesophageal Reflux Disease Dyspepsia	Device: Esophageal Capsule Endoscopy

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy Esophagus Disorders GERD Indigestion

U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

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

Estimated Enrollment:	150
Study Start Date:	September 2005
Study Completion Date:	July 2006

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00217347

Locations

France
Nantes University Hospital
Nantes, France, 44093

Sponsors and Collaborators

Nantes University Hospital

Investigators

Principal Investigator:

Jean Paul Galmiche, MD

Nantes UH

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00217347 History of Changes
Other Study ID Numbers:	BRD/05/3-J
Study First Received:	September 20, 2005
Last Updated:	June 4, 2008
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Nantes University Hospital:

Gastroesophageal reflux
Dyspepsia
Esophageal Capsule Endoscopy

Additional relevant MeSH terms:

Dyspepsia
Gastroesophageal Reflux
Signs and Symptoms, Digestive
Signs and Symptoms
Esophageal Motility Disorders

Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on February 12, 2012