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NCT03442738: Endocuff

A Prospective Randomized Comparison of the Adenoma Detection Rate With a Disposable Cap (ENDOCUFF VISION®)

Completed Last updated 28 June 2023
What this trial tests

trial testing Endocuff group in Adenoma Detection Rate in 1,382 participants. Completed in 30 September 2022.

Timeline
1 September 2017
Primary endpoint
30 September 2021
30 September 2022

Quick facts

Lead sponsorUniversitätsklinikum Hamburg-Eppendorf
StatusCompleted
Study typeOBSERVATIONAL
Enrollment1,382
Start date1 September 2017
Primary completion30 September 2021
Estimated completion30 September 2022
Sites9 locations across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Universitätsklinikum Hamburg-Eppendorf — full company profile →

Who can join

55 and older, any sex, with Adenoma Detection Rate. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 (general practices) and in a homogenous patient collective (screening colonoscopies only). It is a prospective randomized multi centric study, with participation of at least 10 study sites (private practice). The study is an inverstigator-initiated trial (IIT). Depending on the randomization (closed envelope), the patients are examined with the standard instruments without or with ENDOCUFF VISION®. Group 1: screening colonoscopy with standard colonoscopes with ENDOCUFF VISION® Group 2: screening colonoscopy with standard colonoscopes without cap

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Second-generation distal attachment cuff for adenoma detection in screening colonoscopy: a randomized multicenter study.
    Zimmermann-Fraedrich K, Sehner S, Rösch T, Aschenbeck J, et al · · 2023 · cited 9× · PMID 36030888 · DOI 10.1016/j.gie.2022.08.030

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Other recruiting trials for Adenoma Detection Rate

Currently open trials in the same condition.

Other Universitätsklinikum Hamburg-Eppendorf trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03442738.

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