Comparison of AMR and ADR Between Endocuff Vision-assisted and Conventional Colonoscopy: a Multicenter Randomized Trial (EXCEED)

January 25, 2018 updated by: Radboud University Medical Center

Comparison of Adenoma Miss Rate and Adenoma Detection Rate Between Endocuff Vision®-Assisted Colonoscopy and Conventional Colonoscopy: a Multicenter Randomized Trial

The aim of this international multicenter study is to compare the adenoma detection rate and adenoma miss rate of conventional and Endocuff Vision-assisted colonoscopy.

Study Overview

Status

Status

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

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

Rationale: Population screening programs for colorectal cancers (CRC) are increasingly adapted as a public health initiative with the primary goal to prevent CRC and CRC related deaths. [2-4] The ultimate benefit of CRC screening relies on the detection and resection of (pre-)malignant colon lesions, and for this colonoscopy is the preferred modality. Recently, concerns have been raised about the effectiveness of colonoscopy in the prevention of CRC after several studies reported unexpected high incidence rates of interval carcinomas (IC), especially in the proximal colon.[5-9] Most ICs are suspected to arise from missed colon lesions during colonoscopy. The retrograde approach of colonic inspections may contribute to colon lesions remaining undetected as it limits visualization of the proximal sides of haustral folds and flexures. Endocuff Vision® is a single-use, disposable medical device designed to improve the detection of colon lesions. The 'finger-like' projections of the device provide fold retraction allowing the visualization of otherwise hidden anatomical areas. Additionally, Endocuff Vision® may improve scope tip stability and prevent scope slippage.

Objectives:

  1. To compare adenoma miss rates (AMR) between Endocuff Vision®-assisted colonoscopy (EAC) and conventional colonoscopy (CC)
  2. To compare adenoma detection rates (ADR) between EAC and CC
  3. To assess whether a proposed increased ADR and reduced AMR with EAC is indeed due to the fold-flattening device or merely a consequence of the second colonoscopy procedure performed.
  4. To assess the clinical relevance of the polyps missed during the first colonoscopy procedure.

Study design: This multicenter, randomized, same-day, back-to-back tandem colonoscopy trial will include four separate study groups: group A; CC followed by CC, Group B; CC followed by EAC, Group C; EAC followed by CC, and group D; EAC followed by EAC.

Study population: Patients between the ages of 40 and 75-years referred for screening (non-IFOBT based), diagnostic or surveillance colonoscopy.

Main study parameters/endpoints: The primary endpoint of the study will be AMR.

Secondary endpoints include; ADR, mean number of adenomas detected per colonoscopy procedure, number of sessile serrated polyps, the total number of colon lesions found during the first and second examination (which will be compared for size, colon distribution, morphologic and histopathological characteristics), cecal intubation rates, bowel cleansing levels, procedure times, sedation use, (severe) adverse events, patient reported outcome (pain) and post-colonoscopy surveillance intervals applying European and United states surveillance guidelines.

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.
Interventional

Enrollment (Anticipated)

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.
708

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Greece
      • Athens, Greece, 11521
        • Recruiting
        • 417 Army Veterans Hospital
        • Contact:
          • george Alexandrakis
    • Haidari
      • Athens, Haidari, Greece, GR-12462
        • Recruiting
        • "Attikon" University General Hospital,
        • Contact:
          • Ioannis Papanikolaou, MD
  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525GA
        • Recruiting
        • Radboud University Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peter D Siersema, MD

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

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients, aged between 40 and 75-years old, referred and scheduled for either screening (non-FIT/gFOBT based), diagnostic or surveillance colonoscopy.

Exclusion Criteria:

  • Prior surgical resection of any portion of the colon or a history of radiotherapy for any abdominal or pelvic disease.
  • Personal history of colon cancer or polyposis syndrome.
  • Familial adenomatous polyposis (FAP)
  • Known colitis or suspicion of colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis).
  • Lower gastro-intestinal bleeding requiring acute intervention.
  • Suspicion of large bowel obstruction or toxic megacolon.
  • Prior incomplete colonoscopy (not including insufficient preparation).
  • Patients referred for a therapeutic procedure or assessment of a known non-resected lesion.
  • Not sufficiently corrected anticoagulation disorders
  • Poor general condition (>3 American Society of Anesthesiologist)
  • Overweight (>120 kg)
  • Inability to provide informed consent.

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

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
ACTIVE_COMPARATOR: 2 x CC
2 x conventional colonoscopy (CC), back-to-back design
Device: 2x CC
CC = conventional colonoscopy
ACTIVE_COMPARATOR: CC followed by EC
Conventional colonoscopy followed by Endocuff Vision- assisted colonoscopy, back-to-back design
Device: CC followed by EC
CC = conventional colonoscopy EC = endocuff assisted colonoscopy
ACTIVE_COMPARATOR: EC followed by CC
Endocuff Vision-assisted colonoscopy followed by conventional colonoscopy, back-to-back design
Device: EC followed by CC
CC = conventional colonoscopy EC = endocuff assisted colonoscopy
ACTIVE_COMPARATOR: 2 x EC
2 x Endocuff Vision-assisted colonoscopy
Device: 2x EC
EC = endocuff assisted colonoscopy

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 miss rate (%)
Time Frame: 18 months
To compare adenoma miss rates (AMR) between Endocuff Vision®-assisted colonoscopy (EAC) and conventional colonoscopy (CC)
18 months

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
Adenoma detection rate (%)
Time Frame: 18 months
To compare adenoma detection rates (ADR) between Endocuff Vision®-assisted and CC.
18 months
Mean number of adenomas detected per colonoscopy procedure
Time Frame: 18 months
Mean number of adenomas detected per colonoscopy procedure. This will be calculated after the first and second procedure to assess if there is a significant increase.
18 months
Number of sessile serrated lesions per procedure
Time Frame: 18 months
Number of sessile serrated lesions per procedure. This will be calculated after the first and second procedure to assess if there is a significant increase.
18 months
Total number of colon lesions found during first and second examination
Time Frame: 18 months
These polyps will be compared for size, colon distribution (coecum, ascending, transversum, descending, sigmoïd or rectum), morphologic (Paris classification) and histopathological characteristics (Vienna classification)
18 months
Difference in ADR (learning curve first 20% and last 20% by each colonoscopist)
Time Frame: 18 months
To compare the ADR of the first 20% of patients scoped by each colonoscopist with the last 20% of patients in each arm to identify any changes in ADR throughout the trial (to assess a learning curve) between CC and EC
18 months
Cecal intubation rate
Time Frame: 18 months
To compare cecal intubation rates between both techniques.
18 months
Bowel cleansing levels; using the Boston Bowel Preparation Scale (BBPS) ranging from 0-9)
Time Frame: 18 months
To compare BBPS scores between both techniques. A BBPS score of 2 or more in each colon segment is considered adequate.
18 months
Procedure times (minutes)
Time Frame: 18 months
To compare procedure times; total procedure time, insertion time, mean polypectomy time, withdrawal time)
18 months
Number of severe adverse events
Time Frame: 18 months
To compare the number of severe adverse events between study groups. 1 month follow-up
18 months
Sedation and analgesia use; type and amount
Time Frame: 18 months
To compare the use of sedation and analgesia between study groups. Type of sedation and analgesia and amount will be compared
18 months
Post-polypectomy surveillance guidelines; difference in surveillance intervals after the first and second procedure.
Time Frame: 18 months
To compare post-colonoscopy surveillance intervals applying European and US surveillance guidelines.
18 months
To compare patient reported outcomes e.g. pain
Time Frame: 18 months
Visual Analog Scale 2 days and 1 month after the procedure
18 months

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.
Radboud University Medical Center

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

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.
December 8, 2017

Primary Completion (ANTICIPATED)

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 1, 2019

Study Completion (ANTICIPATED)

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.
November 1, 2019

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).
December 18, 2017

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.
January 25, 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 1, 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.
February 1, 2018

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.
January 25, 2018

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.
December 1, 2017

More Information

Terms related to this study

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.
  • EXCEED study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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