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Main
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Note: This record shows only 22 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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ClinicalTrials.gov |
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Last refreshed on:
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13 March 2023 |
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Main ID: |
NCT02197351 |
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Date of registration:
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18/07/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Narrow Band Imaging for Gastric Neoplasia
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Scientific title:
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Prospective Controlled Trial of Narrow Band Imaging for Detection of Gastric Cancer Precursors |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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220 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02197351 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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Portugal
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United States
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Contacts
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Name:
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James Buxbaum, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Southern California |
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Name:
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James Buxabum, MD |
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Address:
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Telephone:
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323 409 5371 |
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Email:
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jbuxbaum@usc.edu |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- presenting for upper endoscopy for gastric indications
- gastric indications include upper abdominal pain dyspepsia abnormal gastric imaging
iron deficiency anemia gastric ulcer management of GI blood loss without active
bleeding reflux weight loss.
Exclusion Criteria:
- Subjects who are incarcerated, younger than 18, or unable to give informed consent
will be excluded.
- Patients who have evidence of active gastrointestinal bleeding will be excluded
- Patients taking anti-thrombotic agents including clopidogrel, ticlopidine, coumadin,
heparin, enoxaparin, and direct II or Xa inhibitors
- Patients with INR >1.5, platelet count <75,000
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Gastric Metaplasia
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Gastric Cancer
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Gastric Dysplasia
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Intervention(s)
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Procedure: White light biopsy
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Procedure: Narrow Band Imaging Guided Biopsy
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Procedure: Protocolled
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Primary Outcome(s)
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Detection of Intestinal Metaplasia or Dysplasia
[Time Frame: One Year]
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Secondary Outcome(s)
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Number of regions with dysplasia
[Time Frame: one year]
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Number of Regions with Intestinal Metaplasia
[Time Frame: 1 year]
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Helicobacter pyrlori detection
[Time Frame: One year]
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Biopsies driven by method
[Time Frame: One year]
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Secondary ID(s)
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HS-14-00418
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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