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

Primary Purpose

Gastroesophageal Reflux Disease, Dyspepsia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Esophageal Capsule Endoscopy
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastroesophageal Reflux Disease focused on measuring Gastroesophageal reflux, Dyspepsia, Esophageal Capsule Endoscopy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Nantes University Hospital

Outcomes

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

Full Information

First Posted
September 20, 2005
Last Updated
June 4, 2008
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00217347
Brief Title
Evaluation of Efficiency of Esophageal Capsule Endoscopy in the Screening of Patients With Gastroesophageal Reflux Disease or Dyspepsia as Compared to Upper Endoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nantes University Hospital

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease, Dyspepsia
Keywords
Gastroesophageal reflux, Dyspepsia, Esophageal Capsule Endoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Esophageal Capsule Endoscopy
Primary Outcome Measure Information:
Title
To determine the parameters of sensitivity, specificity, positive and negative predictive values of the Esophageal Capsule Endoscopy
Secondary Outcome Measure Information:
Title
To compare Esophageal Capsule Endoscopy and upper endoscopy in detection and classification of esophagitis.
Title
To determine the inter-observer agreement for the classification of esophagitis.
Title
To compare Esophageal Capsule Endoscopy and upper endoscopy in detection of stomachal or duodenal lesions.
Title
To evaluate the tolerance of the two examinations

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Paul Galmiche, MD
Organizational Affiliation
Nantes UH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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