Evaluation of Endorings-2-assisted Colonoscopy: a New Accessory for Improvement of Adenoma Detection Rate?
NCT ID: NCT03385434
Last Updated: 2020-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
292 participants
INTERVENTIONAL
2018-02-01
2022-02-01
Brief Summary
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Endorings-2 is a silicone-rubber device that is fitted on the colonoscope and is equipped with circular flexible silicon rings mechanically stretching the colonic folds during withdrawal.
This study aims to evaluate the efficacy of Endorings-2 to improve the adenoma detection rate in a prospective, blinded clinical trial. 292 patients with an indication for a screening colonoscopy shall be included (1:1 randomization in standard colonoscopy versus Endorings-2-assisted colonoscopy).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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Endorings-assisted screening colonoscopy
146 patients with an indication for screening endoscopy will receive an Endorings-2-assisted colonoscopy.
Endorings-2
292 patients with an indication for screening colonoscopy will be included. 146 patients will receive a standard colonoscopy and 146 patients will receive an Endorings-2 assisted colonoscopy (1:1 standard colonoscopy vs Endorings-2-assisted colonoscopy).
Standard screening colonoscopy
146 patients with an indication for screening endoscopy will receive a standard colonoscopy.
No interventions assigned to this group
Interventions
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Endorings-2
292 patients with an indication for screening colonoscopy will be included. 146 patients will receive a standard colonoscopy and 146 patients will receive an Endorings-2 assisted colonoscopy (1:1 standard colonoscopy vs Endorings-2-assisted colonoscopy).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with prior colectomy or partial colectomy
* Patients with a history of colorectal cancer
* Patients with hereditary polyposis syndromes (FAP, HNPCC)
* Patients with a stricture of the colon
* Patients receiving anticoagulation prohibiting a colonoscopy
* inability to have a patient education
* bad conditions prohibiting a colonoscopy
18 Years
99 Years
ALL
Yes
Sponsors
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University Hospital Muenster
OTHER
Responsible Party
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Locations
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Unversity Clinic Muenster
Münster, North Rhine-Westphalia, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2017-635-f-S
Identifier Type: -
Identifier Source: org_study_id
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