Small bowel imaging COmparing Magnetic Resonance enteroclysis and video cApsule with Double-balloon Endoscopy: the COMRADE study

Completed

• Conditions: Small bowel pathology; Signs and Symptoms; Bowel pathology

• Registration Number: ISRCTN78685405
• Lead Sponsor: Schering Nederland BV (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Patients of more than 18 and less than 75 years
2. One of the following patient groups:
2.1. Patients with suspected Crohn?s disease
2.2. Patients with Crohn?s disease, in need of visualisation of the small bowel because of suspected disease activity
2.3. 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

1. Patients with suspected intra-abdominal abscess
2. Abdominal surgery in the six weeks prior to inclusion
3. Patients with clinical suspicion of high grade small bowel obstruction
4. Pregnancy
5. Breastfeeding
6. Inability to swallow the video capsule
7. Presence of a pacemaker or cardioversion device
8. Patients with a history of contrast media reaction and history of allergy (especially asthma)
9. Severe concomitant disease with limited life expectancy
10. 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