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COLONAUX: Comparison of Two Devices During Colonoscopy

Sponsor
Hospital General Universitario Elche (Other)
Overall Status
Completed
CT.gov ID
NCT03197987
Collaborator
(none)
710
Enrollment
1
Location
2
Arms
14
Actual Duration (Months)
50.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Endocuff
  • Device: cap
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
710 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
Endocuff vs Transparent Cap To Increase Adenoma Detection Rate During Colonoscopy
Actual Study Start Date :
Jun 1, 2017
Actual Primary Completion Date :
Jul 31, 2018
Actual Study Completion Date :
Jul 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Endocuff colonoscopy

Endocuff-assisted colonoscopy

Device: Endocuff
Endocuff-assisted colonoscopy
Other Names:
  • non

    		•
    Active Comparator: Cap colonoscopy

    Cap-assisted colonoscopy

    Device: cap
    Cap-assisted colonoscopy
    Other Names:
  • non

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adenoma detection rate [7 days]

      number of patients with at least one adenoma/total number of patients

    Secondary Outcome Measures

    1. mean adenoma per patient [7 days]

      total number of adenoma/total number of patient

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital General Universitario de Elche Elche Alicante Spain 03203

    Sponsors and Collaborators

    • Hospital General Universitario Elche

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    JAVIER SOLA VERA SANCHEZ, M.D, Ph D, Hospital General Universitario Elche
    ClinicalTrials.gov Identifier:
    NCT03197987
    Other Study ID Numbers:
    • ADR-1
    First Posted:
    Jun 23, 2017
    Last Update Posted:
    Nov 7, 2018
    Last Verified:
    Nov 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by JAVIER SOLA VERA SANCHEZ, M.D, Ph D, Hospital General Universitario Elche
    adenoma detection rate
    cap-assisted colonoscopy
    endocuff
    Additional relevant MeSH terms:
    Adenomatous Polyps

    Study Results

    No Results Posted as of Nov 7, 2018