NCT06475560Recruiting
Camera Capsule Endoscopy in the Routine Diagnostic Pathway for Colorectal Diseases
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
The Department of Surgery at Odense University Hospital (OUH) carries out approximately 10,000 colonoscopies each year, and this number is continuously increasing. Since 2014, the screening for colorectal cancer (CRC) has resulted in a significant increase in the colonoscopy workload. Conventional colonoscopy (CC) is a hospital-based procedure that can require sedation or analgesics and is often considered uncomfortable, intimidating, or even painful. The diagnostic yield of CC can be as low as 3-5% in some patient groups, which means that an endoscopist may need to perform 20 to 30 colonoscopies to identify one case requiring treatment. Physical or cultural barriers can also deter patients from attending appointments, leading to missed cancers or precancerous lesions. To address these challenges, an alternative pathway is needed to reduce the colonoscopy burden on the healthcare system while ensuring fewer findings are missed. One solution is to use Colon Capsule Endoscopy (CCE) as a triage tool. This procedure can be performed in outpatient healthcare centers and requires less equipment than an CC. However, CCE offers no therapeutic capability, and individuals with clinically significant findings will still require an CC. A low reinvestigation rate (\<25%-30%) is desirable for patient preference and the economy. Therefore, DanCap will introduce a new pathway that relies on CCE for routine colorectal examinations of symptomatic patients who are expected to have a low rate of positive findings and, consequently, a low reinvestigation rate, and asses the cost of this new pathway.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 800 (estimated)
- First submitted
- 20 Jun 2024
- Start date
- 27 Nov 2024
- Primary completion date
- 1 Aug 2026
- Lead sponsor
- Odense University Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT06475560
What you commit to
- Study type: Interventional
- Planned participants: 800
- From 27 Nov 2024 to the primary completion date, 1 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous OC with poor bowel preparation within the last 5 years
- Previous major surgery of the digestive tract with consequence of an internal derivation or a stoma\*
Other illness
- History of stenosis of the digestive tract
- Known allergies to the bowel preparation regimen
- Have severe kidney disease
Other
- Require hospital admission for inpatient colonoscopy
- Patient is unable to provide oral and written informed consent
- Patient has a pacemaker/defibrillator
- Patient is pregnant or breastfeeding
- Known chronic constipation
- Imaging examination suggestive for a colorectal tumour
- Anamnestic suspicion of microscopic colitis, where biopsy is needed \*including Whipple
Who the study is looking for
- Older than 18 years
- Symptomatic patient referred for colonoscopy assessment
- Able to provide oral and written informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.