Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-28 @ 9:00 PM
Study NCT ID:
NCT04049357
Status:
COMPLETED
Last Update Posted:
2025-10-02
First Post:
2019-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Care for Colon 2015
Sponsor:
Odense University Hospital
Organization:
Study Overview
Official Title:
Colon Capsule Endoscopy in Bowel Cancer Screening. A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CFC2015
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: