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Adenoma Detection RateEndocuffNCT03442738

A Prospective Randomized Comparison of the Adenoma Detection Rate With a Disposable Cap (ENDOCUFF VISION®)

An observational study of Adenoma Detection Rate, run by Universitätsklinikum Hamburg-Eppendorf at 9 sites in Germany.

Completed

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

Official record
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Trial summary

The aim of this study is to evaluate the effect of ENDOCUFF VISION® (caps with soft, about 1 cm long lateral feet of rubber ("Endocuff") to flatten the colon folds) on ADR in a real-life setting (general practices) and in a homogenous patient collective (screening colonoscopies only). Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Adenoma Detection Rate
What is being tested?
Endocuff group
Type of treatment
Surgery or procedure
How many people
1,382 participants
Where
9 sitesGermany
Study dates
1 Sep 2017to 30 Sep 2022
Phase
Observational
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 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Screening Population for Adenoma and CRC

Who may be able to join

  • > 55 years
  • who voluntarily undergo a screening colonoscopy
  • information and signed declaration of consent

Who cannot join

  • symptoms that may indicate a colonic disease
  • rectal/colonic bleeding
  • known colon disease for further diagnosis, e.g. Carcinoma, polyps for erosion, inflammatory bowel disease, stenosis
  • follow-up/surveillance after colon carcinoma surgery or polypectomy
  • anticoagulant drugs that make a biopsy or polypectomy impossible
  • poor general condition (from ASA (American Society of Anesthesiologists Classification) III)
  • partial/incomplete colonoscopy planned

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Germany9 sites

  • Gastroenterologische Spezialpraxis am Wittenbergplatz

    Berlin, 10318

  • Gemeinschaftspraxis Hohenzollerndamm

    Berlin, 10713

  • Gastroenterologie am Bayerischen Platz

    Berlin, 10825

  • Praxis Dr. Mayr

    Berlin, 12163

  • Praxis für Gastroenterologie in Berlin Reinickendorf

    Berlin, 13437

  • Praxis Dr. med. Jens Aschenbeck

    Berlin, 13581

  • Gastropraxis Eppendorfer Baum

    Hamburg, 20249

  • Schwerpunktpraxis CCB Bergedorf

    Hamburg, 21029

  • Magen-Darm-Zentrum, Facharztzentrum Eppendorf

    Hamburg

Other trials in Germany

About this study

Official title: A Prospective Randomized Comparison of the Adenoma Detection Rate in Screening Colonoscopy With and Without a Disposable Cap (ENDOCUFF VISION®)

The aim of this study is to evaluate the effect of ENDOCUFF VISION® (caps with soft, about 1 cm long lateral feet of rubber ("Endocuff") to flatten the colon folds) on ADR in a real-life setting (general practices) and in a homogenous patient collective (screening colonoscopies only).

It is a prospective randomized multi centric study, with participation of at least 10 study sites (private practice). The study is an inverstigator-initiated trial (IIT).

Read more

Depending on the randomization (closed envelope), the patients are examined with the standard instruments without or with ENDOCUFF VISION®.

Group 1: screening colonoscopy with standard colonoscopes with ENDOCUFF VISION® Group 2: screening colonoscopy with standard colonoscopes without cap

Read the detailed description

Colonoscopy is currently the best method for the detection of colon carcinomas and, as precursor, adenomas, since these can also be biopsied and removed. Therefore, the screening colonoscopy was introduced at the end of 2002 (covered by state insurance) from the age of 55. The main quality parameter for outcome quality is the adenoma detection rate (ADR), which correlates with the rate of the carcinomas prevented. However, since even smaller polyps, especially if they are flat or sunken, may be relevant for colon cancer development, the aim of colonoscopy should be to be able to recognize and remove as many adenomas as possible. There is a need to optimize the efficiency of screening colonoscopy by increasing the rate of adenoma detection, as it is known from many studies that approximately 15-30% of adenomas can be missed- even though the adenoma rate in the German screening colonoscopy register continues to increase over the years and currently stands at 28%.

Previous studies on the increase of the adenoma detection rate by endoscopy concerning newer endoscope technologies including conventional caps have been almost entirely negative.

For about 2 years, a newer version of ENDOCUFF VISION® caps (caps with soft, about 1 cm long lateral feet of rubber (Endocuff) to flatten the colon folds) is available which has already been used in about 8,000 colonoscopies in Germany and another 10,000 colonoscopies in Europe; there are no studies on this version of Endocuff caps.

The aim of this study is to evaluate the effect of ENDOCUFF VISION® in a real-life setting (general practices) and in a homogenous patient collective (screening colonoscopies only).

It is a prospective randomized multi centric study, with participation of at least 10 study sites (private practice). The study is an inverstigator-initiated trial (IIT).

A new technique for ADR improvement within colonoscopy can only be tested in a comparative study in two groups comparing the adenoma rate between the two groups. An independent gold standard does not exist in this sense, but the confirmation by the endoscopically taken histology serves as gold standard for the diagnosis adenoma. The alternative of double examinations (tandem colonoscopy) in each patient is in the setting of private practice not feasible.

Depending on the randomization (closed envelope), the patients are examined with the standard instruments without or with ENDOCUFF VISION®.

Group 1: screening colonoscopy with standard colonoscopes with ENDOCUFF VISION® Group 2: screening colonoscopy with standard colonoscopes without cap

Being tested
Endocuff group
Keywords
ADR, adenoma, polyp, colon, screening, colorectal carcinoma (CRC), cap, endoscopy, colonoscopy, private practice
Medical subject headings
Adenoma, Polyps, Colorectal Neoplasms, Anterior polar cataract 2

What participants receive

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

  • Endocuff groupProcedure or surgery

    Endocuff Vision cap on Standard colonoscope

Study groups in NCT03442738
Study groupRoleWhat they receive
Group I Endocuff groupGroup I Endocuff cap use
Receives: Procedure: Endocuff group
Group II standard colonoscopeGroup II standard colonoscope, no further device used
Receives: Procedure: Endocuff group

What is being measured

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

  1. Adenoma Detection Rate (ADR) in the two study groups

    Differences in ADR with or without the new disposable ENDOCUFF VISION® cap. Hypothesis: Endocuff Vision improves the adenoma detection rate (ADR) by about 25% compared to the comparison group.

    Measured: through study completion, an average of 1 year

Secondary outcomes (9)

  1. ADR (all adenoma/all patients)

    ADR (all adenoma/all patients)

    Measured: 12 months

  2. assessment of adenoma subgroups by location

    differences in adenoma subgroups (between intestinal folds with good accessibility, between intestinal folds with poor accessibility, on top of intestinal fold, behind intestinal fold )

    Measured: 12 months

  3. assessment of adenoma subgroups by size

    measured by comparison with size of snare or forceps

    Measured: 12 months

  4. assessment of adenoma subgroups by form

    stem-based, broad-based, flat adenoma

    Measured: 12 months

  5. assessment of adenoma subgroups by histology

    loiw grade intraepithelial neoplasia (LGIN), high grade intraepithelial neoplasia (HGIN), sessile serrated Adenoma (SSA), Carcinoma

    Measured: 12 months

  6. assessment of adenoma subgroups by adjustability

    adjustability of adenoma by colonoscope on a score scale from 1(very good) - 6 (poor)

    Measured: 12 months

  7. assessment of adenoma subgroups by resection practice

    resection of adenoma by biopsy, polypectomy, resection by forceps, none

    Measured: 12 months

  8. Intervention times

    duration of Intervention

    Measured: through study completion, an average of 1 year

  9. procedure technique

    technical aspects of polypectomy/biopsy

    Measured: through study completion, an average of 1 year

Timeline

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

  1. First posted22 Feb 2018
  2. Study start1 Sep 2017
  3. Primary completion30 Sep 2021
  4. Study completion30 Sep 2022

Resources

More details

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

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
1,382 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03442738
Sponsor's protocol ID
PV 5294
Acronym
Endocuff
Status last verified
Jun 2023
First submitted
2 Feb 2018
Last updated
28 Jun 2023
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

  • Corley DA, Jensen CD, Marks AR, Zhao WK, Lee JK, Doubeni CA, Zauber AG, de Boer J, Fireman BH, Schottinger JE, Quinn VP, Ghai NR, Levin TR, Quesenberry CP. Adenoma detection rate and risk of colorectal cancer and death. N Engl J Med. 2014 Apr 3;370(14):1298-306. doi: 10.1056/NEJMoa1309086.

    PubMed 24693890

  • Bretagne JF, Ponchon T. Do we need to embrace adenoma detection rate as the main quality control parameter during colonoscopy? Endoscopy. 2008 Jun;40(6):523-8. doi: 10.1055/s-2007-995786. Epub 2008 May 8. No abstract available.

    PubMed 18464196

  • van Rijn JC, Reitsma JB, Stoker J, Bossuyt PM, van Deventer SJ, Dekker E. Polyp miss rate determined by tandem colonoscopy: a systematic review. Am J Gastroenterol. 2006 Feb;101(2):343-50. doi: 10.1111/j.1572-0241.2006.00390.x.

    PubMed 16454841

  • Brenner H, Altenhofen L, Kretschmann J, Rosch T, Pox C, Stock C, Hoffmeister M. Trends in Adenoma Detection Rates During the First 10 Years of the German Screening Colonoscopy Program. Gastroenterology. 2015 Aug;149(2):356-66.e1. doi: 10.1053/j.gastro.2015.04.012. Epub 2015 Apr 22.

    PubMed 25911510

  • Moriyama T, Uraoka T, Esaki M, Matsumoto T. Advanced technology for the improvement of adenoma and polyp detection during colonoscopy. Dig Endosc. 2015 Apr;27 Suppl 1:40-4. doi: 10.1111/den.12428.

    PubMed 25556542

  • Omata F, Ohde S, Deshpande GA, Kobayashi D, Masuda K, Fukui T. Image-enhanced, chromo, and cap-assisted colonoscopy for improving adenoma/neoplasia detection rate: a systematic review and meta-analysis. Scand J Gastroenterol. 2014 Feb;49(2):222-37. doi: 10.3109/00365521.2013.863964. Epub 2013 Dec 16.

    PubMed 24328858

  • Nagorni A, Bjelakovic G, Petrovic B. Narrow band imaging versus conventional white light colonoscopy for the detection of colorectal polyps. Cochrane Database Syst Rev. 2012 Jan 18;1(1):CD008361. doi: 10.1002/14651858.CD008361.pub2.

    PubMed 22258983

  • 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

  • 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

  • Adler A, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Scheel M, Schroder A, Yenerim T, Wiedenmann B, Gauger U, Roll S, Rosch T. Latest generation, wide-angle, high-definition colonoscopes increase adenoma detection rate. Clin Gastroenterol Hepatol. 2012 Feb;10(2):155-9. doi: 10.1016/j.cgh.2011.10.026. Epub 2011 Nov 2.

    PubMed 22056301

  • Adler A, Aschenbeck J, Yenerim T, Mayr M, Aminalai A, Drossel R, Schroder A, Scheel M, Wiedenmann B, Rosch T. Narrow-band versus white-light high definition television endoscopic imaging for screening colonoscopy: a prospective randomized trial. Gastroenterology. 2009 Feb;136(2):410-6.e1; quiz 715. doi: 10.1053/j.gastro.2008.10.022. Epub 2008 Oct 15.

    PubMed 19014944

  • Adler A, Lieberman D, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Mross M, Scheel M, Schroder A, Keining C, Stange G, Wiedenmann B, Gauger U, Altenhofen L, Rosch T. Data quality of the German screening colonoscopy registry. Endoscopy. 2013 Oct;45(10):813-8. doi: 10.1055/s-0033-1344583. Epub 2013 Sep 9.

    PubMed 24019130

  • Adler A, Pohl H, Papanikolaou IS, Abou-Rebyeh H, Schachschal G, Veltzke-Schlieker W, Khalifa AC, Setka E, Koch M, Wiedenmann B, Rosch T. A prospective randomised study on narrow-band imaging versus conventional colonoscopy for adenoma detection: does narrow-band imaging induce a learning effect? Gut. 2008 Jan;57(1):59-64. doi: 10.1136/gut.2007.123539. Epub 2007 Aug 6.

    PubMed 17681999

Questions about this trial

What is this clinical trial studying?

An observational study of Adenoma Detection Rate, run by Universitätsklinikum Hamburg-Eppendorf at 9 sites in Germany.

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 3 inclusion and 7 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 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Germany. 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 (ADR) in the two study groups (time frame: through study completion, an average of 1 year). 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 NCT03442738, which also lists 21 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 28 Jun 2023.

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