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Comparison of Two Devices During Colonoscopy (COLONAUX)

Primary Purpose

Adenomatous Polyps

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Endocuff
cap
Sponsored by
Hospital General Universitario Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adenomatous Polyps focused on measuring adenoma detection rate, cap-assisted colonoscopy, endocuff

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital General Universitario de Elche

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Endocuff colonoscopy

Cap colonoscopy

Arm Description

Endocuff-assisted colonoscopy

Cap-assisted colonoscopy

Outcomes

Primary Outcome Measures

Adenoma detection rate
number of patients with at least one adenoma/total number of patients

Secondary Outcome Measures

mean adenoma per patient
total number of adenoma/total number of patient

Full Information

First Posted
June 22, 2017
Last Updated
November 5, 2018
Sponsor
Hospital General Universitario Elche
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1. Study Identification

Unique Protocol Identification Number
NCT03197987
Brief Title
Comparison of Two Devices During Colonoscopy
Acronym
COLONAUX
Official Title
Endocuff vs Transparent Cap To Increase Adenoma Detection Rate During Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Universitario Elche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenomatous Polyps
Keywords
adenoma detection rate, cap-assisted colonoscopy, endocuff

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
710 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endocuff colonoscopy
Arm Type
Experimental
Arm Description
Endocuff-assisted colonoscopy
Arm Title
Cap colonoscopy
Arm Type
Active Comparator
Arm Description
Cap-assisted colonoscopy
Intervention Type
Device
Intervention Name(s)
Endocuff
Other Intervention Name(s)
non
Intervention Description
Endocuff-assisted colonoscopy
Intervention Type
Device
Intervention Name(s)
cap
Other Intervention Name(s)
non
Intervention Description
Cap-assisted colonoscopy
Primary Outcome Measure Information:
Title
Adenoma detection rate
Description
number of patients with at least one adenoma/total number of patients
Time Frame
7 days
Secondary Outcome Measure Information:
Title
mean adenoma per patient
Description
total number of adenoma/total number of patient
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Sola Vera, Ph.D.
Organizational Affiliation
Hospital General Universitario de Elche
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General Universitario de Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Citation
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Comparison of Two Devices During Colonoscopy

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