NCT06882993

Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease

Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease - a Prospective Comparison of Pan-Enteric Capsule Endoscopy Versus Ileocolonoscopy Plus MR Enterography or Small-Bowel Capsule Endoscopy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 165 (estimated)
• Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn whether a camera pill examination of the whole bowel can be used to diagnose Crohn's disease instead of colonoscopy and a small bowel examination (either MRI or camera pill) in patients aged 18-40 years suspected of having Crohn's disease. The main question it aims to answer is: How many patients examined with a camera pill examination of the whole bowel will have a complete examination of the whole bowel and have a diagnosis made without need for any more examinations? Researchers will compare with patients examined with colonoscopy and a small bowel examination. Participants will: * Be examined with either a camera pill examination of the whole bowel, or a colonoscopy and a small bowel examination * Have their electronic medical records checked to see if a diagnosis has been made * Have an interview every three months if diagnosed with an inflammatory bowel disease or after a year if no disease was found

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Panenteric capsule endoscopy	Panenteric capsule endoscopy
DIAGNOSTIC_TEST	Ileocolonoscopy	Endoscopic examination of the colon and terminal ileum after bowel preparation.
DIAGNOSTIC_TEST	MRI enterography	MRI of the small bowel
DIAGNOSTIC_TEST	Small bowel capsule endoscopy	Capsule endoscopy of the small bowel

Timeline

• Start date: 2025-02-26
• Primary completion: 2027-08-31
• Completion: 2028-08-31
• First posted: 2025-03-19
• Last updated: 2025-03-19

Locations

5 sites across 2 countries: Denmark, Sweden