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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04651062
Other study ID # 1-16-02-828-17
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2017
Est. completion date April 1, 2020

Study information

Verified date November 2020
Source Herning Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 1178
Est. completion date April 1, 2020
Est. primary completion date December 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
endocuff
Endocuff is a relatively new device which is intended to be attached to the end of the colonoscope.
Procedure:
no endocuff
colonoscopy is performed without endocuff.

Locations

Country Name City State
Denmark Kirurgisk Afdeling Herning Midtjylland

Sponsors (1)

Lead Sponsor Collaborator
Herning Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary adenoma number of adenomas found during colonoscopy 2 weeks
Secondary cecal intubation rate is the cecum reached during the colonoscopy up to 2 hours
Secondary cecal intubation time number of minutes from start procedure to cecum reached up to 2 hours
Secondary withdrawal time number of minutes from cecum reached to end of the procedure, only if no polyps are found up to 60 minutes
Secondary adenoma size size of adenomas detected up to 4 weeks
Secondary adenoma site where in the bowel the adenoma was detected up to 4 weeks
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