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

NCT03442738 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1382

Last updated 2023-06-28

No results posted yet for this study

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 (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

Conditions

  • Adenoma Detection Rate

Interventions

PROCEDURE

Endocuff group

Endocuff Vision cap on Standard colonoscope

Sponsors & Collaborators

  • Norgine

    collaborator INDUSTRY

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Thomas Rösch · Universitätsklinikum Hamburg-Eppendorf

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2021-09-30
Completion
2022-09-30

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03442738 on ClinicalTrials.gov