Status:
COMPLETED
A Prospective Randomized Comparison of the Adenoma Detection Rate With a Disposable Cap (ENDOCUFF VISION®)
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Collaborating Sponsors:
Norgine
Conditions:
Adenoma Detection Rate
Eligibility:
All Genders
55+ years
Brief Summary
The aim of this study is to evaluate the effect of ENDOCUFF VISION® (caps with soft, about 1 cm long lateral feet of rubber ("Endocuff") to flatten the colon folds) on ADR in a real-life setting (gene...
Detailed Description
Colonoscopy is currently the best method for the detection of colon carcinomas and, as precursor, adenomas, since these can also be biopsied and removed. Therefore, the screening colonoscopy was intro...
Eligibility Criteria
Inclusion
- \> 55 years
- who voluntarily undergo a screening colonoscopy
- information and signed declaration of consent
Exclusion
- symptoms that may indicate a colonic disease
- rectal/colonic bleeding
- known colon disease for further diagnosis, e.g. Carcinoma, polyps for erosion, inflammatory bowel disease, stenosis
- follow-up/surveillance after colon carcinoma surgery or polypectomy
- anticoagulant drugs that make a biopsy or polypectomy impossible
- poor general condition (from ASA (American Society of Anesthesiologists Classification) III)
- partial/incomplete colonoscopy planned
Key Trial Info
Start Date :
September 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
1382 Patients enrolled
Trial Details
Trial ID
NCT03442738
Start Date
September 1 2017
End Date
September 30 2022
Last Update
June 28 2023
Active Locations (9)
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1
Gastroenterologische Spezialpraxis am Wittenbergplatz
Berlin, Germany, 10318
2
Gemeinschaftspraxis Hohenzollerndamm
Berlin, Germany, 10713
3
Gastroenterologie am Bayerischen Platz
Berlin, Germany, 10825
4
Praxis Dr. Mayr
Berlin, Germany, 12163