Small bowel imaging COmparing MR Enteroclysis and Video CApsule with Double-Balloon Endoscopy; the COMRADE study

• Conditions: M. Crohn; obscure gastrointestinal bleeding; 10017943; 10017991

• Registration Number: NL-OMON30347
• Lead Sponsor: Medisch Centrum Alkmaar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

1. Patients of >18 and < 75 years
2. One of the following patient groups:
a. Patients with suspected Crohn*s disease
b. Patients with Crohn*s disease, in need of visualization of the small bowel because of suspected disease activity.
c. Patients with signs of chronic or repeated gastrointestinal bleeding with negative gastroscopy and colonoscopy
3. Patients must be able to give informed consent and the consent must be obtained prior to any study procedures

Exclusion Criteria

Patients will be excluded in case of:
- Abdominal surgery in the 6 weeks prior to inclusion
- Pregnancy
- Breastfeeding
- Inability to swallow the video capsule
- Presence of a pacemaker or cardioversion device
- Severe concomitant disease with limited life expectancy
- A psychiatric, addictive, or any disorder that compromises ability to give truly informed consent for participation in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified