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Completed

NCT Number: NCT04651062

Detection of Adenomas in Screening Colonoscopy

The Endocuff study aims to show an increase of the number of detected adenomas in screening colonoscopies when a endocuff vision (Arc Medical Design Ldt Leeds England) is used.

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Key information

Conditions

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kirurgisk Afdeling

Herning, Central Jutland, 7400, Denmark

About this study

Endocuff is a relatively new device which is intended to be attached to the end of the colonoscope. Several minor studies have shown that the use of Endocuff probably increases the number of detected polyps in colonoscopy. Endocuff is made of soft plastic and has been designed to give an optimal view of the entire colon. It gently averts and flattens folds in order to see small polyps "hiding" in the space behind colonic folds.

The purpose of this study is to investigate into the effect of the Endocuff in screening colonoscopy compared with screening colonoscopy performed without Endocuff. The device has been used during several years yet an effect on the number of polyps detected during screenings colonoscopy has not been shown. This studies main hypothesis is that the use of Endocuff in screenings colonoscopy will increase the adenoma detection rate in these patients, with a potential to reduce interval cancer.

This study is a randomized controlled trial with 900 patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all Citizens participating in the national bowel screening program

Exclusion criteria

  • persons who are disabled and who do not understand the Danish language
  • persons treated with Marcoumar, Marevan, Eliquis, Pradaxa e.g. and who are not eligible to polyp resection
  • persons who due to diseases of the eyes or Heart are not allowed to receive Buscopan.
  • persons with active colitis/diverticulitis, colon stenosis e.g. due to cancer, where a complete colonoscopy is not possible to achieve

Treatment and study plan

endocuff

Device

Endocuff is a relatively new device which is intended to be attached to the end of the colonoscope.

no endocuff

Procedure

colonoscopy is performed without endocuff.

Primary outcomes

  1. adenoma

    Time frame: 2 weeks

    number of adenomas found during colonoscopy

Secondary outcomes

  1. cecal intubation rate

    Time frame: up to 2 hours

    is the cecum reached during the colonoscopy

  2. cecal intubation time

    Time frame: up to 2 hours

    number of minutes from start procedure to cecum reached

  3. withdrawal time

    Time frame: up to 60 minutes

    number of minutes from cecum reached to end of the procedure, only if no polyps are found

  4. adenoma size

    Time frame: up to 4 weeks

    size of adenomas detected

  5. adenoma site

    Time frame: up to 4 weeks

    where in the bowel the adenoma was detected

Sponsors and collaborators

Lead sponsor

Herning Hospital

Other

Registry information

Official study title

Detection of Adenomas in Screening Colonoscopy - Endocuff Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Dec 3, 2020
Registry last updated
Dec 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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