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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitätsklinikum Hamburg-Eppendorf

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Norgine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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