Comparative Study of the Magnetically Guided Capsule Endoscopy Versus High Definition Gastroscopy
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
|Official Title:||"EVALUATION CLINIQUE D'UNE CAPSULE A GUIDAGE MAGNETIQUE POUR L'EXPLORATION GASTRIQUE "Capsule Dirigée Versus Gastroscopie à Haute Définition""|
- Accuracy of magnetically guided capsule endoscopy (MGCE) as compared to unblinded gastroscopy in the diagnosis of focal lesions. [ Time Frame: 2 days ] [ Designated as safety issue: No ]To evaluate the accuracy of MGCE, which is performed by the first examiner. After the MGCE examination, conventional gastroscopy is performed by the second examiner and then the results of the two studies are compared.
- Accuracy of capsule endoscopy in the diagnosis of diffuse and minor lesions [ Time Frame: 2 days ] [ Designated as safety issue: No ]- Accuracy of capsule endoscopy in the diagnosis of diffuse and minor lesions [ Time Frame: within 2 days ] [ Designated as safety issue: No ]
- Examination times of capsule and conventional gastroscopy [ Time Frame: 1 hour ] [ Designated as safety issue: No ]Examination times of capsule and conventional gastroscopy
- Patient acceptance of capsule gastroscopy and conventional gastroscopy [ Time Frame: 2 days ] [ Designated as safety issue: No ]
Patient acceptance of capsule gastroscopy and conventional gastroscopy
- After the two examinations are finished, patients fill out the questionnaire.
- Adverse events of both procedures [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]Adverse events of both procedures
|Study Start Date:||November 2011|
|Study Completion Date:||June 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
patients requiring upper GI endoscopy
patients with upper abdominal complaints requiring upper GI endoscopy
Device: Magnetically Guided Capsule (MGCE)
"a) MGCE capsule The MGCE capsule is custom-made for observation of the stomach. It is 31 mm in length and 11 mm in diameter and equipped with two image sensors.
It contains a permanent magnet to enable magnetic guidance in the stomach by magnetic field." "b) Guidance system The magnet guidance system is custom-made to guide the MGCE capsule inside the stomach. It has a footprint of 1m× 2m and generates a very low level magnetic fields." c) Conventional gastroscope
The sudy takes place in a private hospital (Institute Arnault Tzanck, St. Laurent du Var) with an annual number of 4000 upper GI endoscopies. Patients will be recruited from this center and from the cooperating Department of Gastroenterology at the University of Nice by about half. After given written informed consent at least 24 hours prior the examination patients are included into the study. The examiners are blinded to the patients origin.
Participants will be recruited in two groups A) enriched population group (n=50): In both institutions, patients presenting for upper GI endoscopy with suspected or diagnosed focal lesions as follows; gastric tumors, submucosal tumor, gastric ulcer, polyp a)adenoma, b)hyperplastic polyp or angioectasia,ulcers for diagnostic confirmation, follow-up or planning of therapy will be informed and asked to participate in the study.
B) standard gastroscopy group (n=150): consecutive patients without prior gastroscopy presenting with the main indications reflux, upper abdominal complaints, anemia and anorexia. Here, recruitment is based on presenting symptoms.
6 endoscopists experienced in upper GI endoscopy (> 1000 examinations) and specifically trained in capsule gastroscopy (simulator, 10 gastric capsule cases) will perform capsule gastroscopy. 2 well trained endoscopists (> 1000 upper GI endoscopies), different from the capsule gastroscopists will perform subsequent gastroscopies. They receive standard information about gastroscopy indication from a list of indications. They are accompanied by a study nurse who knows patient details but ascertains examiner blindness and takes care of secondary unblinding during gastroscopy.
Gastroscopy is always performed after MGCE in this study with a maximum delay of 1 day but a minimum delay of 4 h due to water filling of the stomach with the capsule examination.
The study is a comparative study of capsule gastroscopy accuracy with conventio¬nal gastroscopy serving as gold standard as described above. Disease prevalence is enriched to include 25-30% of significant pathology such as tumors and ulcers. Confidence intervals will be calculated, e.g. for a disease prevalence of about 30% and 200 study cases, a sensitivity of 85% will have a 95% CI of 73-93%. Cross tabulation of the results of the index tests (including indeterminate and missing results) will be performed by the results of the reference standard. Study statistics will be done by Prof. Dr. Karl Wegscheider, University Hospital Hamburg/Eppendorf.
All patient data will be collected at Institut Arnault Tzanck in St. Laurent du Var. Data will be analyzed in pseudonymity way (code, age, sex) at the University of Hamburg. Original data will be stored for 10 years at Institut Arnault Tzanck in St. Laurent du Var
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555840
|Institut Arnault Tzanck , Avenue du Docteur Maurice Donat|
|Saint-Laurent du Var, Cote Azur, France, 06721|
|Principal Investigator:||J F Rey, MD||Institut Arnault Tzanck, St. Laurent du Var, France|