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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00434551




Registration number
NCT00434551
Ethics application status
Date submitted
11/02/2007
Date registered
13/02/2007
Date last updated
26/03/2009

Titles & IDs
Public title
MACCS: Multicenter Australian CE in Patients With Suspected Crohn's Disease Study
Scientific title
Evaluation of Capsule Endoscopy in Patients With Suspected Small Bowel Crohn's Disease
Secondary ID [1] 0 0
MA-36
Universal Trial Number (UTN)
Trial acronym
MACCS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Diseases 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1 - Patients with suspected Crohn's disease

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
• To evaluate the yield of capsule endoscopy for the diagnosis of small bowel Crohn's disease in symptomatic patients with non-diagnostic standard work-up.
Timepoint [1] 0 0
end of study
Secondary outcome [1] 0 0
• To assess the clinical impact made by CE in patients with clinically suspected small bowel Crohn's disease
Timepoint [1] 0 0
end of study

Eligibility
Key inclusion criteria
- 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 a-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
Minimum age
10 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [3] 0 0
Repatriation General Hospital - Daw Park
Recruitment hospital [4] 0 0
Eastern Health - Box Hill
Recruitment hospital [5] 0 0
St. Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [6] 0 0
Cabrini Medical Centre - Malvern
Recruitment hospital [7] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [8] 0 0
Sir Charles Gardiner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
5041 - Daw Park
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3144 - Malvern
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment postcode(s) [8] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Given Imaging Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
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. Patients will be randomized to undergo capsule endoscopy either one week or
five weeks after enrolment. Patients will be followed up for up to 3 months after capsule
endoscopy.
Trial website
https://clinicaltrials.gov/show/NCT00434551
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Warwick Selby, MD
Address 0 0
Royal Prince Alfred Hospital, Sydney, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications