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

June 27, 2023 updated by: Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf

A Prospective Randomized Comparison of the Adenoma Detection Rate in Screening Colonoscopy With and Without a Disposable Cap (ENDOCUFF VISION®)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 introduced at the end of 2002 (covered by state insurance) from the age of 55. The main quality parameter for outcome quality is the adenoma detection rate (ADR), which correlates with the rate of the carcinomas prevented. However, since even smaller polyps, especially if they are flat or sunken, may be relevant for colon cancer development, the aim of colonoscopy should be to be able to recognize and remove as many adenomas as possible. There is a need to optimize the efficiency of screening colonoscopy by increasing the rate of adenoma detection, as it is known from many studies that approximately 15-30% of adenomas can be missed- even though the adenoma rate in the German screening colonoscopy register continues to increase over the years and currently stands at 28%.

Previous studies on the increase of the adenoma detection rate by endoscopy concerning newer endoscope technologies including conventional caps have been almost entirely negative.

For about 2 years, a newer version of ENDOCUFF VISION® caps (caps with soft, about 1 cm long lateral feet of rubber (Endocuff) to flatten the colon folds) is available which has already been used in about 8,000 colonoscopies in Germany and another 10,000 colonoscopies in Europe; there are no studies on this version of Endocuff caps.

The aim of this study is to evaluate the effect of ENDOCUFF VISION® 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).

A new technique for ADR improvement within colonoscopy can only be tested in a comparative study in two groups comparing the adenoma rate between the two groups. An independent gold standard does not exist in this sense, but the confirmation by the endoscopically taken histology serves as gold standard for the diagnosis adenoma. The alternative of double examinations (tandem colonoscopy) in each patient is in the setting of private practice not feasible.

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

Study Type

Observational

Enrollment (Actual)

1382

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10318
        • Gastroenterologische Spezialpraxis am Wittenbergplatz
      • Berlin, Germany, 10713
        • Gemeinschaftspraxis Hohenzollerndamm
      • Berlin, Germany, 10825
        • Gastroenterologie am Bayerischen Platz
      • Berlin, Germany, 12163
        • Praxis Dr. Mayr
      • Berlin, Germany, 13437
        • Praxis für Gastroenterologie in Berlin Reinickendorf
      • Berlin, Germany, 13581
        • Praxis Dr. med. Jens Aschenbeck
      • Hamburg, Germany, 20249
        • Gastropraxis Eppendorfer Baum
      • Hamburg, Germany, 21029
        • Schwerpunktpraxis CCB Bergedorf
      • Hamburg, Germany
        • Magen-Darm-Zentrum, Facharztzentrum Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Screening Population for Adenoma and CRC

Description

Inclusion Criteria:

  • > 55 years
  • who voluntarily undergo a screening colonoscopy
  • information and signed declaration of consent

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group I Endocuff group
Group I Endocuff cap use
Procedure: Endocuff group
Endocuff Vision cap on Standard colonoscope
Group II standard colonoscope
Group II standard colonoscope, no further device used
Procedure: Endocuff group
Endocuff Vision cap on Standard colonoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma Detection Rate (ADR) in the two study groups
Time Frame: through study completion, an average of 1 year
Differences in ADR with or without the new disposable ENDOCUFF VISION® cap. Hypothesis: Endocuff Vision improves the adenoma detection rate (ADR) by about 25% compared to the comparison group.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ADR (all adenoma/all patients)
Time Frame: 12 months
ADR (all adenoma/all patients)
12 months
assessment of adenoma subgroups by location
Time Frame: 12 months
differences in adenoma subgroups (between intestinal folds with good accessibility, between intestinal folds with poor accessibility, on top of intestinal fold, behind intestinal fold )
12 months
assessment of adenoma subgroups by size
Time Frame: 12 months
measured by comparison with size of snare or forceps
12 months
assessment of adenoma subgroups by form
Time Frame: 12 months
stem-based, broad-based, flat adenoma
12 months
assessment of adenoma subgroups by histology
Time Frame: 12 months
loiw grade intraepithelial neoplasia (LGIN), high grade intraepithelial neoplasia (HGIN), sessile serrated Adenoma (SSA), Carcinoma
12 months
assessment of adenoma subgroups by adjustability
Time Frame: 12 months
adjustability of adenoma by colonoscope on a score scale from 1(very good) - 6 (poor)
12 months
assessment of adenoma subgroups by resection practice
Time Frame: 12 months
resection of adenoma by biopsy, polypectomy, resection by forceps, none
12 months
Intervention times
Time Frame: through study completion, an average of 1 year
duration of Intervention
through study completion, an average of 1 year
procedure technique
Time Frame: through study completion, an average of 1 year
technical aspects of polypectomy/biopsy
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaborators

Norgine

Investigators

  • Principal Investigator: Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

February 2, 2018

First Submitted That Met QC Criteria

February 20, 2018

First Posted (Actual)

February 22, 2018

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 27, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PV 5294

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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