Camera capsule endoscopy for routine colorectal diagnosis

Camera Capsule Endoscopy in the Routine Diagnostic Pathway for Colorectal Diseases

This trial tests whether colon capsule endoscopy can be used instead of or before conventional in-hospital colonoscopy for adults referred for colorectal evaluation.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 800 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Odense University Hospital (other)
• Locations: 1 site (Odense C)
• Trial ID: NCT06475560 on ClinicalTrials.gov

What this trial studies

Adults referred for colonoscopic assessment are assigned to either an out-of-hospital colon capsule endoscopy (CCE) pathway or conventional colonoscopy (CC) to compare diagnostic yield, downstream procedures, and service burden. The trial enrolls symptomatic adults able to provide informed consent and excludes those with suspected tumors on imaging, severe comorbidities, prior major gastrointestinal surgery with stoma, pacemakers, pregnancy, chronic constipation, or other contraindications. Key outcomes include diagnostic quality, rates of required re-investigation or therapeutic follow-up, and impacts on endoscopy workload and patient pathway. The protocol aims to define realistic thresholds for treating versus observing small lesions and to test whether CCE can safely decongest hospital endoscopy services.

Who should consider this trial

Good fit: Ideal candidates are adults referred for colonoscopy who can give written informed consent and do not have exclusions such as suspected colorectal tumor, significant bowel stenosis, prior major GI surgery with stoma, pacemaker/defibrillator, pregnancy, severe kidney disease, known chronic constipation, or allergy to bowel prep.

Not a fit: Patients requiring inpatient or therapeutic colonoscopy, those with imaging suggestive of a colorectal tumor, those needing biopsy for suspected microscopic colitis, or anyone with contraindications to capsule passage are unlikely to benefit from the CCE pathway.

Why it matters

Potential benefit: If successful, CCE could reduce the number of uncomfortable, hospital-based colonoscopies and expand access to bowel diagnostics while easing endoscopy service workload.

How similar studies have performed: Large implementations in Scotland and England and several clinical trials have shown CCE to be safe and diagnostically high-quality in routine use, but consistently high (45–60%) re-investigation rates remain a major limitation.

Eligibility criteria

Inclusion Criteria:

* Older than 18 years
* Symptomatic patient referred for colonoscopy assessment
* Able to provide oral and written informed consent

Exclusion criteria

1. Require hospital admission for inpatient colonoscopy
2. Previous OC with poor bowel preparation within the last 5 years
3. Patient is unable to provide oral and written informed consent
4. History of stenosis of the digestive tract
5. Previous major surgery of the digestive tract with consequence of an internal derivation or a stoma\*
6. Patient has a pacemaker/defibrillator
7. Patient is pregnant or breastfeeding
8. Known allergies to the bowel preparation regimen
9. Have severe kidney disease
10. Known chronic constipation
11. Imaging examination suggestive for a colorectal tumour
12. Anamnestic suspicion of microscopic colitis, where biopsy is needed \*including Whipple

Where this trial is running

Odense C

• Odense University Hospital — Odense C, Denmark (RECRUITING)

Study contacts

• Principal investigator: Anastasios Koulaouzidis, Professor — OUH og Svendborg Sygehus
• Study coordinator: Anastasios Koulaouzidis, Professor

Conditions: Colorectal Cancer, colorectal cancer, capsule endoscopy, colonoscopy