Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06475560

Camera Capsule Endoscopy in the Routine Diagnostic Pathway for Colorectal Diseases

Led by Odense University Hospital · Updated on 2026-03-19

800

Participants Needed

1

Research Sites

91 weeks

Total Duration

On this page

Sponsors

O

Odense University Hospital

Lead Sponsor

R

Region Syddanmark

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Camera Capsule Endoscopy in the Routine Diagnostic Pathway for Colorectal Diseases

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Older than 18 years
  • Symptomatic patient referred for colonoscopy assessment
  • Able to provide oral and written informed consent
Not Eligible

You will not qualify if you...

  • Require hospital admission for inpatient colonoscopy
  • Previous colonoscopy with poor bowel preparation within the last 5 years
  • Unable to provide oral and written informed consent
  • History of digestive tract narrowing (stenosis)
  • Previous major digestive tract surgery resulting in internal diversion or stoma
  • Presence of pacemaker or defibrillator
  • Pregnant or breastfeeding
  • Known allergies to bowel preparation regimen
  • Severe kidney disease
  • Known chronic constipation
  • Imaging suggesting colorectal tumor
  • Suspicion of microscopic colitis requiring biopsy, including Whipple disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Odense University Hospital

Odense C, Denmark, 5000

Actively Recruiting

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Research Team

A

Anastasios Koulaouzidis, Professor

CONTACT

A

Alexandra D Agache, Postdoc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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