Skip to main content
Clinical Trials/NCT04049357
NCT04049357
Completed
Not Applicable

Colon Capsule Endoscopy in Bowel Cancer Screening. A Randomized Controlled Trial

Odense University Hospital1 site in 1 country2,031 target enrollmentAugust 3, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
Odense University Hospital
Enrollment
2031
Locations
1
Primary Endpoint
CCE detection rate of polyps compared to OC
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

The investigatior believe that implementing camera capsule endoscopy as a filter test to colonoscopy will increase screening participation, increase the number of individuals with detected intermediate- high risk adenomas or cancer, reduce the colonoscopy demand and reduce the number of complications.

Detailed Description

The Danish national colorectal cancer screening program includes all citizens aged 50-74 years, who are invited biennially to a fecal test for invisible blood in the stool. If the test is positive the citizen is invited for a colonoscopy. 90% of the test-positive undergo colonoscopy. The detected cancers are at a significant earlier stage and survival from screening detected cancer is higher. It is also expected that cancer incidence will drop due to removal of the advanced adenomas before they develop into cancer. Although initial results are positive, there is room for improvement. Additionally there are rare but serious complications to colonoscopy in the form of bleeding or bowel perforation. Through four years the investigators have tested the colon capsule endoscopy method, and find that the investigation is associated with significantly less discomfort and that the diagnostic ability to find polyps \> 1 cm is better than colonoscopy.

Registry
clinicaltrials.gov
Start Date
August 3, 2020
End Date
October 1, 2024
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Participation in the Danish colorectal screening program

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

CCE detection rate of polyps compared to OC

Time Frame: Within 30 days

The investigators aim to conduct a large scale randomized trial to investigate the implementation of CCE as part of the Danish screening protocol.

Study Sites (1)

Loading locations...

Similar Trials