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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02331836 |
Date of registration:
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02/01/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy
EC-Cap-SC |
Scientific title:
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Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy for Adenoma Detection: A Randomized Controlled European Multicenter Study |
Date of first enrolment:
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February 2015 |
Target sample size:
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561 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02331836 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Factorial 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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Germany
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Poland
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Contacts
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Name:
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Tobias Meister, Prof. Dr.med. |
Address:
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Telephone:
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Email:
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Affiliation:
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Helios Albert-Schweitzer-Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Colonoscopy independent from indication
- Age = 18
- Patient is able to provide informed consent for the procedure
Exclusion Criteria:
- Inflammatory Bowel Disease stenosis
- Pregnant of nursing patient
- Acute diverticulitis
- Active Inflammatory Bowel Disease
- Age = 18
- Coagulation disorder (INR>1.4 , Thrombocytes < 50000/µl)
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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Colorectal Adenomas
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Colorectal Polyps
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Intervention(s)
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Device: Arc Endocuff (AEC 110, 120, 130, 140)
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Device: Cap
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Device: Standard colonoscope
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Primary Outcome(s)
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Adenoma detection rate
[Time Frame: 1 year]
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Polyp detection rate
[Time Frame: 1 year]
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Secondary Outcome(s)
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mucosal laceration
[Time Frame: one day]
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Bowel preparation result
[Time Frame: one day]
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severe bleeding
[Time Frame: one day]
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Coecum intubation rate
[Time Frame: one year]
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Coecum intubation time
[Time Frame: one day]
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perforation
[Time Frame: one day]
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Ileum intubation rate
[Time Frame: one year]
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withdrawal time
[Time Frame: one day]
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Secondary ID(s)
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EC-CUFF-2015
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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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