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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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8 August 2016 |
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Main ID: |
NCT02340065 |
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Date of registration:
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13/01/2015 |
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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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Endocuff-assisted vs. Standard Colonoscopy
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Scientific title:
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Endocuff-assisted vs. Standard Colonoscopy: a Randomized, Back-to-Back Study |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02340065 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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Greece
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Contacts
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Name:
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KONSTANTINOS TRIANTAFYLLOU, PROF |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Institute, Attikon University General Hospital, University of Athens, Greece |
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Name:
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DIMITRIOS POLYMEROS, 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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Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Institute, Attikon University General Hospital, University of Athens, Greece |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- adults undergoing elective screening or surveillance colonoscopy
- symptomatic adults with indication for colonoscopy
Exclusion Criteria:
- age<18 and > 80 years
- poor overall health (ASA III, IV)
- recent abdominal surgery
- presence of abdominal wall hernias
- active colitis
- previous bowel resection
- inflammatory bowel disease
- polyposis syndromes
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Colon Neoplasms
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Intervention(s)
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Procedure: Endocuff-assisted colonoscopy
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Procedure: standard colonoscopy
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Primary Outcome(s)
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number and rate of missed adenomas
[Time Frame: one week]
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Secondary Outcome(s)
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number of adenomas and adenoma detection rate in the right colon
[Time Frame: one week]
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number of polyps and polyp detection rate in the entire colon
[Time Frame: one week]
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number of adenomas and adenoma detection rate in the entire colon
[Time Frame: one week]
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intubation and withdrawal time
[Time Frame: one week]
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mean number of adenomas per procedure
[Time Frame: one week]
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colonoscopy completion (colonoscopy completion rate, reason for incomplete colonoscopy)
[Time Frame: one week]
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adverse events
[Time Frame: one week]
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endoscopist's satisfaction (quantified using a scale from 0 (not satisfied) to 10 (completely satisfied)
[Time Frame: one week]
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number of polyps and polyp detection rate in the right colon
[Time Frame: one week]
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Secondary ID(s)
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ENDOCUFF-001
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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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