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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
Universal Trial Number (UTN)
Trial acronym
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

Study type
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

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

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
Both males and females
Can healthy volunteers participate?
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
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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
Given Imaging Ltd.

Ethics approval
Ethics application status

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
Trial website
Trial related presentations / publications
Public notes

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