AzTrials
AzTrials

Adenomatous PolypsCOLONAUXNCT03197987

Comparison of Two Devices During Colonoscopy

A study testing Endocuff and cap in people with Adenomatous Polyps, run by Hospital General Universitario Elche at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adenomatous Polyps
What is being tested?
Endocuff and cap
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
710 participants
Where
1 siteSpain
Study dates
1 Jun 2017to 31 Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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;
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

Other trials in Spain

About this study

Official title: 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.

Read the 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

Being tested
Endocuff, cap
Keywords
adenoma detection rate, cap-assisted colonoscopy, endocuff
Medical subject headings
Adenomatous Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EndocuffDevice

    Also called non

    Endocuff-assisted colonoscopy

  • capDevice

    Also called non

    Cap-assisted colonoscopy

Study groups in NCT03197987
Study groupRoleWhat they receive
Endocuff colonoscopyExperimentalEndocuff-assisted colonoscopy
Receives: Device: Endocuff
Cap colonoscopyActive comparatorCap-assisted colonoscopy
Receives: Device: cap

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adenoma detection rate

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

    Measured: 7 days

Secondary outcomes (1)

  1. mean adenoma per patient

    total number of adenoma/total number of patient

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2017
  2. Study start1 Jun 2017
  3. Primary completion31 Jul 2018
  4. Study completion31 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
710 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03197987
Sponsor's protocol ID
ADR-1
Acronym
COLONAUX
Status last verified
Nov 2018
First submitted
22 Jun 2017
Last updated
7 Nov 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 20463339

  • 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.

    PubMed 25470133

  • 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.

    PubMed 26674360

  • 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

  • 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.

    PubMed 24921209

  • 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.

    PubMed 19716434

  • 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.

    PubMed 21997547

  • 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.

    PubMed 20579648

  • 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.

    PubMed 24338756

  • 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.

    PubMed 22187070

  • 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.

    PubMed 21328306

  • 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.

    PubMed 26126162

  • 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.

    PubMed 31096275

Questions about this trial

What is this clinical trial studying?

A study testing Endocuff and cap in people with Adenomatous Polyps, run by Hospital General Universitario Elche at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adenoma detection rate (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03197987, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in