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

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ClinicalTrials.gov Identifier: NCT03442738
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : June 6, 2019
Sponsor:
Collaborator:
Norgine
Information provided by (Responsible Party):
Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf

Brief 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).

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).

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


Condition or disease Intervention/treatment
Adenoma Detection Rate Procedure: Endocuff group

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


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Study Type : Observational
Estimated Enrollment : 1382 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Randomized Comparison of the Adenoma Detection Rate in Screening Colonoscopy With and Without a Disposable Cap (ENDOCUFF VISION®)
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020

Group/Cohort Intervention/treatment
Group I Endocuff group
Group I Endocuff cap use
Procedure: Endocuff group
Endocuff Vision cap on Standard colonoscope

Group II standard colonoscope
Group II standard colonoscope, no further device used
Procedure: Endocuff group
Endocuff Vision cap on Standard colonoscope




Primary Outcome Measures :
  1. Adenoma Detection Rate (ADR) in the two study groups [ Time Frame: through study completion, an average of 1 year ]
    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.


Secondary Outcome Measures :
  1. ADR (all adenoma/all patients) [ Time Frame: 12 months ]
    ADR (all adenoma/all patients)

  2. assessment of adenoma subgroups by location [ Time Frame: 12 months ]
    differences in adenoma subgroups (between intestinal folds with good accessibility, between intestinal folds with poor accessibility, on top of intestinal fold, behind intestinal fold )

  3. assessment of adenoma subgroups by size [ Time Frame: 12 months ]
    measured by comparison with size of snare or forceps

  4. assessment of adenoma subgroups by form [ Time Frame: 12 months ]
    stem-based, broad-based, flat adenoma

  5. assessment of adenoma subgroups by histology [ Time Frame: 12 months ]
    loiw grade intraepithelial neoplasia (LGIN), high grade intraepithelial neoplasia (HGIN), sessile serrated Adenoma (SSA), Carcinoma

  6. assessment of adenoma subgroups by adjustability [ Time Frame: 12 months ]
    adjustability of adenoma by colonoscope on a score scale from 1(very good) - 6 (poor)

  7. assessment of adenoma subgroups by resection practice [ Time Frame: 12 months ]
    resection of adenoma by biopsy, polypectomy, resection by forceps, none

  8. Intervention times [ Time Frame: through study completion, an average of 1 year ]
    duration of Intervention

  9. procedure technique [ Time Frame: through study completion, an average of 1 year ]
    technical aspects of polypectomy/biopsy



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Screening Population for Adenoma and CRC
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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): NCT03442738


Contacts
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Contact: Thomas Rösch, Prof. +49 40 7410 ext 50098 t.roesch@uke.de
Contact: Tania Noder +49 40 7410 ext 50089 t.noder@uke.de

Locations
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Germany
Gastroenterologische Spezialpraxis am Wittenbergplatz Recruiting
Berlin, Germany, 10318
Contact: Gastroenterologische Spezialpraxis am Wittenbergplatz    +49 30 5293310    info@dr-mross.de   
Principal Investigator: Michael Mroß, Dr         
Gemeinschaftspraxis Hohenzollerndamm Recruiting
Berlin, Germany, 10713
Contact: Gemeinschaftspraxis Hohenzollerndamm    +49 308647640    schroeder@schonack-schroeder.de   
Contact: Gemeinschaftspraxis Hohenzollerndamm       nehm@schonack-schroeder.de   
Principal Investigator: Andreas Schröder, Dr.         
Sub-Investigator: Klaus Nehm, Dr.         
Gastroenterologie am Bayerischen Platz Recruiting
Berlin, Germany, 10825
Contact: Gastroenterologie am Bayerischen Platz    +49 30 81459190    gastroenterologen@berlin.de   
Sub-Investigator: Thomas Liceni, Dr.         
Sub-Investigator: Peter Armerding, Dr.         
Principal Investigator: Stefan Schubert, Dr.         
Praxis Dr. Mayr Recruiting
Berlin, Germany, 12163
Contact: Praxis Dr. Mayr    +49 30 7912041    info@praxis-mayr.de   
Principal Investigator: Michael Mayr, Dr.         
Sub-Investigator: Frank Heller, Dr.         
Praxis für Gastroenterologie in Berlin Reinickendorf Recruiting
Berlin, Germany, 13437
Contact: Praxis für Gastroenterologie in Berlin Reinickendorf    +49 30 40914570    praxis@aminalai.de   
Principal Investigator: Alireza Aminalai, Dr.         
Praxis Dr. med. Jens Aschenbeck Recruiting
Berlin, Germany, 13581
Contact: Praxis Dr. med. Jens Aschenbeck    +49 30 3314444    info@aschenbeck-berlin.de   
Principal Investigator: Jens Aschenbeck, Dr.         
Gastropraxis Eppendorfer Baum Not yet recruiting
Hamburg, Germany, 20249
Contact: Gastropraxis Eppendorfer Baum    +49 40+471103660    info@gastropraxis-eppendorferbaum.de   
Principal Investigator: Michael Bläker, PD Dr.         
Sub-Investigator: Beate Keck, Dr.         
Sub-Investigator: Nina Hansen-Rosenblatt, Dr.         
Schwerpunktpraxis CCB Bergedorf Not yet recruiting
Hamburg, Germany, 21029
Contact: Schwerpunktpraxis CCB Bergedorf    +49 40 72005020    info@sp-ccb.de   
Principal Investigator: Wolfgang Burmeister, Dr.         
Sub-Investigator: Katrin Niemax, Dr.         
Magen-Darm-Zentrum, Facharztzentrum Eppendorf Not yet recruiting
Hamburg, Germany
Contact: Magen-Darm-Zentrum, Facharztzentrum Eppendorf    +49 40 360 35 22 ext 0    prof.miehlke@mdz-hamburg.de   
Principal Investigator: Stephan Miehlke, Prof. Dr.         
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Norgine
Investigators
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Principal Investigator: Thomas Rösch Universitätsklinikum Hamburg-Eppendorf

Publications:

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Responsible Party: Prof. Dr. Thomas Rösch, Prof. Dr. med., Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03442738     History of Changes
Other Study ID Numbers: PV 5294
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf:
ADR
adenoma
polyp
colon
screening
colorectal carcinoma (CRC)
cap
endoscopy
colonoscopy
private practice

Additional relevant MeSH terms:
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Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms