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Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities (ADENOMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02552017
Recruitment Status : Unknown
Verified September 2015 by South Tyneside and Sunderland NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : September 16, 2015
Last Update Posted : September 16, 2015
Sponsor:
Information provided by (Responsible Party):
South Tyneside and Sunderland NHS Foundation Trust

Brief Summary:
The purpose of this study is to determine if a new device, called the Endocuff Vision (a small plastic device attached to the end of the colonoscope which helps by holding the folds of the bowel back to give a clear view of the inside of the bowel) will significantly improve the detection of adenomas when used in all patients referred for colonoscopy.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Colonic Polyps Adenoma Device: Endocuff Vision Not Applicable

Detailed Description:

Bowel cancer is common in the United Kingdom, with around 1 in 16 men and 1 in 20 women developing it at some point in their lives. Most bowel cancers happen when a type of polyp (a growth in the bowel) called an adenoma becomes cancerous. Doctors use a camera test, known as a colonoscopy, to look inside the bowel and find these polyps and remove them. Removing precancerous polyps is known to reduce the chances of a person developing bowel cancer in the future. How good colonoscopists are at finding these polyps varies, and there is a lot of research into how to improve "adenoma detection rates".

A new device, called the Endocuff Vision (a small plastic device attached to the end of the colonoscope which helps by holding the folds of the bowel back to give a clear view of the inside of the bowel) has been shown to improve the rate of polyp detection at colonoscopy, and to make polyp removal easier. Previous small studies have shown that there is a significant improvement in detection of adenomas when an Endocuff Vision is used (with the rate of detection of adenomas rising from 49% to 66%). Colonoscopists who have used the Endocuff Vision before also feel that polyp removal is easier when it is on the colonoscope. This study will randomise patients coming for colonoscopy to have their procedure performed as usual (i.e. without the Endocuff Vision attached) or as an Endocuff Vision-assisted colonoscopy. The investigators will record polyp and adenoma detection rates, duration of procedure, participant comfort levels, and complications. All patients referred for colonoscopy (via the symptomatic service, surveillance procedures, and the Bowel Cancer Screening Programme) will be invited in 7 centres (a mixture of specialist centres and district general hospitals), recruiting a total of 1772 participants.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1772 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities
Study Start Date : November 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Active Comparator: Endocuff Vision-assisted Colonoscopy
Participants in this arm undergo Endocuff Vision-assisted colonoscopy
Device: Endocuff Vision
Endocuff Vision is a new device made of soft plastic material with a unique dynamic shape. It is manufactured by ARC Medical Design Limited and Diagmed in the United Kingdom. It has European Conformity in United Kingdom. The core is made of polypropylene and the 'finger like' projections are made of a thermoplastic elastomer. It comes in four colour coded sizes (purple, blue, green and orange) to fit a range of paediatric and adult colonoscopes. Endocuff Vision is the more updated version of device that has only one proximal row of more rounded finger-like projections. It is mounted at the tip of the colonoscope and held on by friction (pull-off force is a minimum of 10 Newtons).

No Intervention: Standard Colonoscopy
Participants in this arm undergo standard colonoscopy



Primary Outcome Measures :
  1. Adenoma detection rate [ Time Frame: 10 months ]
    A difference in adenoma detection rate between Endocuff Vision-assisted colonoscopy and standard colonoscopy.


Secondary Outcome Measures :
  1. Mean adenomas detected per procedure [ Time Frame: 10 months ]
    A difference in mean adenomas detected per procedure between both groups

  2. Rate of cuff exchange [ Time Frame: 10 months ]
    The rate of cuff exchange (that is, how often the cuff has to be removed) between both groups

  3. Effect on duration of caecal intubation rates [ Time Frame: 10 months ]
    Duration of complete withdrawal time in procedures where no polyps are detected between both groups

  4. Patient satisfaction using validated patient comfort Bowel Cancer Screening Programme (BCSP) questionnaires [ Time Frame: 10 months ]
    Patient satisfaction measured from no pain (0) to severe pain (3), episodes of discomfort from no discomfort (0) to frequent (more than 4 times)(3), length of discomfort from no discomfort (0) to more than 1 minute(3).

  5. Increase in surveillance colonoscopies caused by increased adenoma detection rate [ Time Frame: 10 months ]
    Increase in surveillance colonoscopies due to increased adenoma detection rate in terms of number of potential follow up procedures based on British Society of Gastroenterology adenoma surveillance guidelines in both groups

  6. Number of proximal sessile serrated polyps by histology [ Time Frame: 10 months ]
    Number of of proximal sessile serrated polyps in both groups

  7. Polyp location [ Time Frame: 10 months ]
    Distribution of polyps in the colon in both groups by location

  8. Adenoma detection rate of BCSP and non-BCSP endoscopists [ Time Frame: 10 months ]
    Adenoma detection rate of BCSP and non-BCSP colonoscopists

  9. Change in adenoma detection rate of each endoscopist during the course of the trial [ Time Frame: 10 months ]
    Adenoma detection rate (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.

  10. Adenoma detection rate of individual endoscopist before and after trial commencement [ Time Frame: 10 months ]
    Baseline ADR of each colonoscopist prior to trial recruitment with their individual ADR in patients where Endocuff Vision was not used.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. All patients referred for screening, surveillance, or diagnostic colonoscopy
  2. All patients must be able to give informed consent

Exclusion Criteria:

  1. Patients with any absolute contraindications to colonoscopy
  2. Patients with established or suspicion of large bowel obstruction or pseudo-obstruction
  3. Patients with known colon cancer or polyposis syndromes
  4. Patients with known colonic strictures
  5. Patients with known severe diverticular segments (that is likely to impede colonoscope passage)
  6. Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
  7. Patients lacking capacity to give informed consent
  8. Pregnancy
  9. Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure.
  10. Patients who are attending for a therapeutic procedure or assessment of a known lesion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02552017


Contacts
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Contact: Wee Sing Ngu, MBChB, MRCS 01914041000 ext 2899 wngu@nhs.net
Contact: Gayle Clifford, BSc 01914041000 ext 4756 gayle.clifford@stft.nhs.uk

Locations
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United Kingdom
County Durham and Darlington NHS Foundation Trust Recruiting
Durham, County Durham, United Kingdom, DL3 6HX
Contact: John Silcock, MBBS, FRCP    01325 380100    John.Silcock@cddft.nhs.uk   
Principal Investigator: John Silcock, MBBS, FRCP         
North Tees and Hartlepool NHS Foundation Trust Recruiting
Stockton-on-Tees, County Durham, United Kingdom, TS19 8PE
Contact: Matthew Rutter, MBBS, FRCP    01642 617617    Matt.rutter@nth.nhs.uk   
Principal Investigator: Matthew Rutter, MBBS, FRCP         
St Mark's Hospital and Academic Institute Recruiting
Harrow, Middlesex, United Kingdom, HA1 3UJ
Contact: Brian Saunders, MBBS, FRCP    02082354000    b.saunders@imperial.ac.uk   
Principal Investigator: Brian Saunders, MBBS, FRCP         
South Tees Hospitals NHS Foundation Trust Recruiting
Middlesbrough, North Yorkshire, United Kingdom, TS4 3BW
Contact: Arvind Ramadas, MBBS, FRCP    01642 854860    Arvind.Ramadas@stees.nhs.uk   
Principal Investigator: Arvind Ramadas, MBBS,FRCP         
Northumbria Healthcare NHS Foundation Trust Recruiting
North Shields, Tyne and Wear, United Kingdom, NE29 8NH
Contact: Thomas Lee, MBBS, FRCP    0344 811 8111    Tom.Lee@northumbria-healthcare.nhs.uk   
Principal Investigator: Thomas Lee, MBBS, FRCP         
South Tyneside NHS Foundation Trust Recruiting
South Shields, Tyne and Wear, United Kingdom, NE34 0PL
Contact: Wee Sing Ngu, MBChB, MRCS    01914041000 ext 2899    wngu@nhs.net   
Contact: Gayle Clifford, BSc    01914041000 ext 4756    gayle.clifford@stft.nhs.uk   
Principal Investigator: Colin Rees, MBBS, FRCP         
City Hospitals Sunderland NHS Foundation Trust Recruiting
Sunderland, Tyne and Wear, United Kingdom, SR4 7TP
Contact: John Painter, MBBS, FRCP    0191 565 6256    John.Painter@chsft.nhs.uk   
Principal Investigator: John Painter, MBBS, FRCP         
Sponsors and Collaborators
South Tyneside and Sunderland NHS Foundation Trust
Investigators
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Principal Investigator: Colin Rees, MBBS, FRCP South Tyneside and Sunderland NHS Foundation Trust
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: South Tyneside and Sunderland NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02552017    
Other Study ID Numbers: 039/2014
17718 ( Registry Identifier: UK Clinical Research Network )
1182104 ( Registry Identifier: International Standard Randomised Controlled Trial Number )
First Posted: September 16, 2015    Key Record Dates
Last Update Posted: September 16, 2015
Last Verified: September 2015
Keywords provided by South Tyneside and Sunderland NHS Foundation Trust:
adenoma detection rate
Endocuff
Endocuff Vision
colonoscopy
bowel cancer screening
bowel cancer
Additional relevant MeSH terms:
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Adenoma
Colorectal Neoplasms
Colonic Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical