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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
NTR867 |
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Date of registration:
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08/01/2007 |
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Primary sponsor: |
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Public title:
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ETMI vs. standard video endoscopy for the detection of early neoplasia in patients with low-grade dysplasia in a Barrett's esophagus: a multi-center randomized cross-over controlled study
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Scientific title:
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ETMI vs. standard video endoscopy for the detection of early neoplasia in patients with low-grade dysplasia in a Barrett's esophagus: a multi-center randomized cross-over controlled study - GETMI |
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Date of first enrolment:
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1/1/2007 |
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Target sample size:
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96 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=867 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Not applicable; Group: Crossover; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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J.J.G.H.M.
Bergman |
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Address:
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Academic Medical Center
Bldg. C2-210, Meibergdreef
1105 AZ
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5669111 |
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Email:
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j.j.bergman@amc.uva.nl |
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Affiliation:
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Name:
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J.J.G.H.M.
Bergman |
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Address:
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Academic Medical Center
Bldg. C2-210, Meibergdreef
1105 AZ
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5669111 |
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Email:
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j.j.bergman@amc.uva.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Barrett's esophagus patients with low-grade dyplasia comfirmed by two expert GI pathologists;
2. Written informed consent
Exclusion criteria: 1. Presence of active erosive esophagitis grade A according to the Los Angles classification of erosive esophagitis;
2. Presence of conditions precluding histological sampling of the esophagus (e.g. esophageal varices, coagulation disorders, anticoagulant therapy);
3. < 18 years
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Barrett's esophagus
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Intervention(s)
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ETMI-gastroscopy and standard video gastroscopy
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Primary Outcome(s)
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1. Number of patients with early neoplasia detected with ETMI or SVE;
2. Number of lesions with early neoplasia detected with ETMI and SVE.
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Secondary Outcome(s)
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1. Number of early neoplastic lesions detected with AFI only;
2. Reduction of false positives findings after detailed NBI evaluation.
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Secondary ID(s)
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ISRCTN91816824
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N/A
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Source(s) of Monetary Support
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ZON-MW, The Netherlands Organization for Health Research and Development
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