Status:
COMPLETED
MACCS: Multicenter Australian CE in Patients With Suspected Crohn's Disease Study
Lead Sponsor:
Medtronic - MITG
Conditions:
Inflammatory Bowel Diseases
Eligibility:
All Genders
10+ years
Brief Summary
This is a prospective study aimed to validate the ability of capsule endoscopy to accurately diagnose small bowel Crohn's disease in symptomatic patients who have a non-diagnostic standard workup. Pat...
Detailed Description
In the past few years, capsule endoscopy has sparked renewed interest in the investigation of small bowel Crohn's disease. A PillCam™SB capsule (Given Imaging Ltd, Yoqneam, Israel) is an ingestible, d...
Eligibility Criteria
Inclusion
- Patient will be 10 years and older
- Patient suffers from abdominal pain and/or diarrhea for the last 6 weeks and/or expresses extra-intestinal manifestations of CD
- Patient has at least one of the following over the preceding 6 months (plus symptoms suspicious of small bowel Crohn's Disease):
- Positive inflammatory marker (ESR, CRP, thrombocytosis, leucocytosis, fecal lactoferrin, fecal α-1 antitrypsin)
- Unexplained anemia,
- Recurrent fever,
- Weight loss (at least 10% of normal body weight in adults),
- Hypoalbuminaemia (\<3.5 g/dL),
- Gastro-intestinal bleeding,
- Chronic perianal disease (fistula, fissure),
- Abnormal white cell scan
- Positive ASCA
- First degree relative of a person suffering from IBD (only for subjects without known IBD),
- Patient underwent standard evaluation that includes colonoscopy and attempted ileoscopy and also SBFT within six months prior to enrollment, which were non-diagnostic. Blood tests should have been done within one month of enrolment.
- Patient or legal guardian agrees to sign the Informed Consent Form
Exclusion
- Patients with indeterminate colitis where the purpose is only to make a definitive diagnosis and where the inclusion criteria are not otherwise met
- Patient is known to suffer from intestinal obstruction (symptoms such as severe abdominal pain with accompanying nausea or vomiting)
- Definite stricture seen on SBFT
- Patient had suspected GI stricture, a Given® Patency capsule was administered and Patient did not pass the Patency capsule.
- Patient has a pacemaker or other implanted electro-medical device
- Patient has known history of small bowel Crohn's disease
- Patient on treatment for active IBD
- Patient with suspected celiac disease that has not been excluded
- Patient on non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or higher) during the 3 months preceding enrolment
- Patient is pregnant
- Patient has any condition, which precludes compliance with study and/or device instructions, such as swallowing problems
- Patient suffers from life threatening conditions
- Patient is currently participating in another clinical study that may directly or indirectly affect the results of this study
Key Trial Info
Start Date :
February 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT00434551
Start Date
February 1 2005
End Date
February 1 2008
Last Update
July 31 2019
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
2
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
3
Repatriation General Hospital
Daw Park, South Australia, Australia, 5041
4
Eastern Health
Box Hill, Victoria, Australia, 3128