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Completed

NCT Number: NCT00217347

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

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.

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Dyspepsia Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantes University Hospital

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esophageal Capsule Endoscopy

Device

Primary outcomes

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

Secondary outcomes

  1. To compare Esophageal Capsule Endoscopy and upper endoscopy in detection and classification of esophagitis.

  2. To determine the inter-observer agreement for the classification of esophagitis.

  3. To compare Esophageal Capsule Endoscopy and upper endoscopy in detection of stomachal or duodenal lesions.

  4. To evaluate the tolerance of the two examinations

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Important dates

Study start
2005
Study completion
2006
First posted
Sep 22, 2005
Registry last updated
Jun 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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