NCT04049357

Care for Colon 2015

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,031 (actual)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer
• Adenoma

Interventions

Type	Name	Description
DEVICE	Camera Capsule Endoscopy/ PillCam	Camera Capsule Endoscopy in screening

Timeline

• Start date: 2020-08-03
• Primary completion: 2024-01-31
• Completion: 2024-10-01
• First posted: 2019-08-08
• Last updated: 2025-10-02

Locations

1 site across 1 country: Denmark

Regulatory

• FDA-regulated device study