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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: |
NCT03117114 |
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Date of registration:
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08/04/2017 |
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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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Endocuff Vision Assisted vs. Standard Polyp Resection in the Colorectum
EVASTA |
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Scientific title:
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Endocuff Vision Assisted vs. Standard Polyp Resection in the Colorectum |
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Date of first enrolment:
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June 1, 2017 |
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Target sample size:
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250 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03117114 |
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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: Prevention. Masking: None (Open Label).
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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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Contacts
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Name:
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Peter Klare, 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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Technische Universität München |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- indication for colonoscopy
- age = 40 years
Exclusion Criteria:
- American Society of Anesthesiologists class IV or higher
- pregnant women
- indication for colonoscopy: inflammatory bowel disease
- indication for colonoscopy: polyposis syndrome
- indication for colonoscopy: emergency colonoscopy e.g. acute bleeding
- contraindication for polyp resection e.g. patients on warfarin
Exclusion Criteria:
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Age minimum:
18 Years
Age maximum:
95 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Colon Polyp
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Intervention(s)
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Other: Standard polypectomy
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Device: Endocuff Vision assisted polypectomy
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Primary Outcome(s)
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Polyp resection
[Time Frame: up to 1 day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day)]]
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Secondary Outcome(s)
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Cecal intubation time
[Time Frame: up to day 1]
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Total procedure duration
[Time Frame: up to day 1]
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Polyp detection
[Time Frame: up to day 1]
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Complications
[Time Frame: up to day 1]
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Ileum intubation time
[Time Frame: up to day 1]
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Patient satisfaction
[Time Frame: up to day 1]
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Propofol dosage
[Time Frame: up to 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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