- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03197987
Comparison of Two Devices During Colonoscopy (COLONAUX)
Endocuff vs Transparent Cap To Increase Adenoma Detection Rate During Colonoscopy
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alicante
-
Elche, Alicante, Spain, 03203
- Hospital General Universitario de Elche
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
Active Comparator: Cap colonoscopy
Cap-assisted colonoscopy
|
Cap-assisted colonoscopy
Other Names:
|
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
Investigators
- Principal Investigator: Javier Sola Vera, Ph.D., Hospital General Universitario de Elche
Publications and helpful links
General Publications
- Kaminski MF, Regula J, Kraszewska E, Polkowski M, Wojciechowska U, Didkowska J, Zwierko M, Rupinski M, Nowacki MP, Butruk E. Quality indicators for colonoscopy and the risk of interval cancer. N Engl J Med. 2010 May 13;362(19):1795-803. doi: 10.1056/NEJMoa0907667.
- Rastogi A, Bansal A, Rao DS, Gupta N, Wani SB, Shipe T, Gaddam S, Singh V, Sharma P. Higher adenoma detection rates with cap-assisted colonoscopy: a randomised controlled trial. Gut. 2012 Mar;61(3):402-8. doi: 10.1136/gutjnl-2011-300187. Epub 2011 Oct 13.
- Floer M, Biecker E, Fitzlaff R, Roming H, Ameis D, Heinecke A, Kunsch S, Ellenrieder V, Strobel P, Schepke M, Meister T. Higher adenoma detection rates with endocuff-assisted colonoscopy - a randomized controlled multicenter trial. PLoS One. 2014 Dec 3;9(12):e114267. doi: 10.1371/journal.pone.0114267. eCollection 2014.
- van Doorn SC, van der Vlugt M, Depla A, Wientjes CA, Mallant-Hent RC, Siersema PD, Tytgat K, Tuynman H, Kuiken SD, Houben G, Stokkers P, Moons L, Bossuyt P, Fockens P, Mundt MW, Dekker E. Adenoma detection with Endocuff colonoscopy versus conventional colonoscopy: a multicentre randomised controlled trial. Gut. 2017 Mar;66(3):438-445. doi: 10.1136/gutjnl-2015-310097. Epub 2015 Dec 16.
- Biecker E, Floer M, Heinecke A, Strobel P, Bohme R, Schepke M, Meister T. Novel endocuff-assisted colonoscopy significantly increases the polyp detection rate: a randomized controlled trial. J Clin Gastroenterol. 2015 May-Jun;49(5):413-8. doi: 10.1097/MCG.0000000000000166.
- Marsano J, Tzimas D, Mckinley M, et al. Endocuff assisted colonoscopy increases adenoma detection rates: a multi-center study. Gastrointest Endosc 2014;79(5 Suppl):AB550
- Horiuchi A, Nakayama Y, Kato N, Ichise Y, Kajiyama M, Tanaka N. Hood-assisted colonoscopy is more effective in detection of colorectal adenomas than narrow-band imaging. Clin Gastroenterol Hepatol. 2010 Apr;8(4):379-83. doi: 10.1016/j.cgh.2009.08.018. Epub 2009 Aug 26.
- Hewett DG, Rex DK. Cap-fitted colonoscopy: a randomized, tandem colonoscopy study of adenoma miss rates. Gastrointest Endosc. 2010 Oct;72(4):775-81. doi: 10.1016/j.gie.2010.04.030. Epub 2010 Jun 25.
- Frieling T, Neuhaus F, Kuhlbusch-Zicklam R, Heise J, Kreysel C, Hulsdonk A, Blank M, Czypull M. Prospective and randomized study to evaluate the clinical impact of cap assisted colonoscopy (CAC). Z Gastroenterol. 2013 Dec;51(12):1383-8. doi: 10.1055/s-0033-1335637. Epub 2013 Dec 11.
- de Wijkerslooth TR, Stoop EM, Bossuyt PM, Mathus-Vliegen EM, Dees J, Tytgat KM, van Leerdam ME, Fockens P, Kuipers EJ, Dekker E. Adenoma detection with cap-assisted colonoscopy versus regular colonoscopy: a randomised controlled trial. Gut. 2012 Oct;61(10):1426-34. doi: 10.1136/gutjnl-2011-301327. Epub 2011 Dec 20.
- Morgan J, Thomas K, Lee-Robichaud H, Nelson RL. Transparent Cap Colonoscopy versus Standard Colonoscopy for Investigation of Gastrointestinal Tract Conditions. Cochrane Database Syst Rev. 2011 Feb 16;(2):CD008211. doi: 10.1002/14651858.CD008211.pub2.
- Pohl H, Bensen SP, Toor A, Gordon SR, Levy LC, Berk B, Anderson PB, Anderson JC, Rothstein RI, MacKenzie TA, Robertson DJ. Cap-assisted colonoscopy and detection of Adenomatous Polyps (CAP) study: a randomized trial. Endoscopy. 2015 Oct;47(10):891-7. doi: 10.1055/s-0034-1392261. Epub 2015 Jun 30.
- Sola-Vera J, Catala L, Uceda F, Pico MD, Perez Rabasco E, Saez J, Jimenez N, Arjona MD, Fernandez M, Girona E, Garcia-Sepulcre MF. Cuff-assisted versus cap-assisted colonoscopy for adenoma detection: results of a randomized study. Endoscopy. 2019 Aug;51(8):742-749. doi: 10.1055/a-0901-7306. Epub 2019 May 16.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADR-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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