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NCT04049357 Clinical Trial

Care for Colon 2015

Colorectal Cancer Clinical Trial

— CFC2015  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04049357
Other study ID # 0
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2020
Est. completion date October 1, 2024

Study information
Verified date September 2021
Source Odense University Hospital
Contact Gunnar Baatrup, Professor
Phone 0045 20575154
Email Gunnar.Baatrup@rsyd.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2015
Est. completion date October 1, 2024
Est. primary completion date October 1, 2022
Accepts healthy volunteers No
Gender All
Age group 50 Years to 74 Years
Eligibility Inclusion Criteria: - Participation in the Danish colorectal screening program Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Camera Capsule Endoscopy/ PillCam
Camera Capsule Endoscopy in screening

Locations
Country Name City State
Denmark Odense University Hospital, Svendborg Sygehus Svendborg

Sponsors (1)
Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary CCE detection rate of polyps compared to OC The investigators aim to conduct a large scale randomized trial to investigate the implementation of CCE as part of the Danish screening protocol. Within 30 days
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