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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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12 December 2020 |
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Main ID: |
NCT03015571 |
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Date of registration:
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29/12/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Influence of Routine Use of Narrow Band Imaging on Heterotopic Gastric Mucosa of the Proximal Esophagus Detection
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Scientific title:
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Influence of Routine Use of Narrow Band Imaging on Heterotopic Gastric Mucosa of the Proximal Esophagus Detection |
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Date of first enrolment:
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January 10, 2017 |
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Target sample size:
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1000 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03015571 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel 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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Poland
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Referral for diagnostic gastroscopy
- Ability to undergo diagnostic gastroscopy
- Provided written informed consent
Exclusion Criteria:
- Age <18
- Prisoners
- Pregnancy
- Gastroscopy with treatment procedure
- Inability to provide informed consent
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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Heterotopic Gastric Mucosa of the Proximal Esophagus
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Intervention(s)
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Device: Esophagus inspection in Narrow Band imaging and increased care.
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Device: Esophagus inspection in Narrow Band imaging.
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Device: Standard High definition endoscopy and increased care.
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Device: Standard High definition endoscopy.
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Primary Outcome(s)
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Detection of heterotopic gastric mucosa in the proximal esophagus
[Time Frame: Day 1]
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Secondary Outcome(s)
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Correlation of throat and esophageal reflux symptoms with cervical inlet patches
[Time Frame: Day 1]
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Rate of cervical inlet patches verified with NBI in endoscopies performed in standard white light endoscopy
[Time Frame: Day 1]
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Correlation of subject's subjective purpose of gastroscopy and cervical inlet patch occurrence
[Time Frame: Day 1]
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Detection of other upper gastrointestinal lesions
[Time Frame: Day 1]
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Total and esophagus inspection time
[Time Frame: Day 1]
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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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