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

Gastroesophageal Reflux Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00217347
• Other study ID #: BRD/05/3-J
• Status: Completed
• Phase: N/A
• First received: September 20, 2005
• Last updated: June 4, 2008
• Start date: September 2005
• Est. completion date: July 2006

Study information

• Verified date: June 2008
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Dyspepsia
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Device:
• Esophageal Capsule Endoscopy

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the parameters of sensitivity, specificity, positive and negative predictive values of the Esophageal Capsule Endoscopy
Secondary	To compare Esophageal Capsule Endoscopy and upper endoscopy in detection and classification of esophagitis.
Secondary	To determine the inter-observer agreement for the classification of esophagitis.
Secondary	To compare Esophageal Capsule Endoscopy and upper endoscopy in detection of stomachal or duodenal lesions.
Secondary	To evaluate the tolerance of the two examinations