Comparison of Two Devices During Colonoscopy (COLONAUX)

November 5, 2018 updated by: JAVIER SOLA VERA SANCHEZ, Hospital General Universitario Elche

Endocuff vs Transparent Cap To Increase Adenoma Detection Rate During Colonoscopy

Colonoscopy is the gold standard investigation for the diagnosis of bowel pathology and colorectal cancer screening. Adenoma detection rate is a marker of high quality colonoscopy. In this study we compare two devices: Endocuff (TM) and cap that can increase the adenoma detection rate during colonoscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Colonoscopy is the gold standard investigation for the diagnosis of bowel pathology and colorectal cancer screening. Adenoma detection rate is a marker of high quality colonoscopy and a high adenoma detection rate is associated with a lower incidence of interval cancers. Several technological advancements have been explored to improve adenoma detection rate. Endocuff Vision™ has been shown to improve adenoma detection rate in several studies. Cap-assisted colonoscopy is a technique that allow improved visualization of the colonic folds by flattening the fold within the viewing field. However, studies have reported mixed results on adenoma detection in cap-assisted colonoscopy.

This is a prospective, single-centre, randomized controlled trial comparing the adenoma detection rate in patients undergoing Endocuff Vision™-assisted colonoscopy versus cap-assisted colonoscopy. Patients are randomized according to bowel cancer screening status to receive Endocuff Vision™-assisted colonoscopy or cap colonoscopy on the day of procedure. Baseline data, colonoscopy, and polyp data including histology are collected. Patients are followed up at 30 days for complications. This study will take place in an University Hospital in Spain. A maximum of 9 expert colonoscopists will recruit a total of 712 patients.

This is the first trial to evaluate the adenoma detection rate of Endocuff Vision™ vs cap colonoscopy in all screening, surveillance, and diagnostic patient groups. This study will guide clinicians to decide what device to use to increase adenoma detection rate in routine colonoscopy

Study Type

Interventional

Enrollment (Actual)

710

Phase

  • 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 Locations

    • Alicante
      • Elche, Alicante, Spain, 03203
        • Hospital General Universitario de Elche

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients who are attending for screening, surveillance or diagnostic colonoscopy.

Exclusion Criteria:

  • patients with absolute contraindications to colonoscopy;
  • patients with established or suspicion of large bowel obstruction or pseudo-obstruction;
  • patients with known colonic strictures;
  • patients with a known severe diverticular segment (that is likely to impede colonoscope passage);
  • patients with active or known colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis);
  • patients lacking capacity to give informed consent;
  • patients on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure;
  • patients who are attending for a therapeutic procedure or assessment of a known lesion, or submitted for rectoscopy or rectosigmoidoscopy;
  • examination performed by a non-expert colonoscopist;
  • pregnancy.

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endocuff colonoscopy
Endocuff-assisted colonoscopy
Endocuff-assisted colonoscopy
Other Names:
  • non
Active Comparator: Cap colonoscopy
Cap-assisted colonoscopy
Cap-assisted colonoscopy
Other Names:
  • non

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma detection rate
Time Frame: 7 days
number of patients with at least one adenoma/total number of patients
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean adenoma per patient
Time Frame: 7 days
total number of adenoma/total number of patient
7 days

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Javier Sola Vera, Ph.D., Hospital General Universitario de Elche

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)

June 1, 2017

Primary Completion (Actual)

July 31, 2018

Study Completion (Actual)

July 31, 2018

Study Registration Dates

First Submitted

June 22, 2017

First Submitted That Met QC Criteria

June 22, 2017

First Posted (Actual)

June 23, 2017

Study Record Updates

Last Update Posted (Actual)

November 7, 2018

Last Update Submitted That Met QC Criteria

November 5, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

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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