Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000511639
Ethics application status
Approved
Date submitted
14/09/2005
Date registered
26/09/2005
Date last updated
26/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Multicenter Australian Capsule Endoscopy in patients with suspected Crohn's disease Study
Scientific title
Evaluation of Capsule Endoscopy in Patients with Suspected Small Bowel Crohn's Disease
Universal Trial Number (UTN)
Trial acronym
MACCS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suspected Small Bowel Crohn's Disease 636 0
Condition category
Condition code
Cancer 708 708 0 0
Bowel - Small bowel (duodenum and ileum
Oral and Gastrointestinal 709 709 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective study aimed to validate the ability of capsule endoscopy to accurately diagnose small bowel Crohns 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.
Intervention code [1] 611 0
None
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 863 0
The number of patients in whom small bowel Crohn's disease is diagnosed using capsule endoscopy where the standard workup was non-diagnostic. Patients will be randomized to undergo capsule endoscopy either one week or five weeks after enrolment.
Timepoint [1] 863 0
Secondary outcome [1] 1729 0
Clinical assessment (SF 36, IBDQ, CDAI) in different stages of the study.
Timepoint [1] 1729 0
Base line (at the time of enrolment before capsule endoscopy).
Secondary outcome [2] 1730 0
Clinical assessment (SF 36, IBDQ, CDAI) in different stages of the study.
Timepoint [2] 1730 0
1 month after enrolment.
Secondary outcome [3] 1731 0
Clinical assessment (SF 36, IBDQ, CDAI) in different stages of the study.
Timepoint [3] 1731 0
1 month after capsule endoscopy (group 2).
Secondary outcome [4] 1732 0
Clinical assessment (SF 36, IBDQ, CDAI) in different stages of the study.
Timepoint [4] 1732 0
3 months after capsule endoscopy.

Eligibility
Key inclusion criteria
1. Patient suffers from abdominal pain and/or diarrhea for the last 6 weeks and/or expresses extra-intestinal manifestations of CD. 2.Patient has at least one of the following over the preceding 6 months (plus symptoms suspicious of small bowel Crohns Disease): oPositive inflammatory marker (ESR, CRP, thrombocytosis, leucocytosis, fecal lactoferrin, fecal antitrypsin)ounexplained anemia,orecurrent fever,oweight loss (at least 10% of normal body weight in adults),ohypoalbuminaemia (<3.5 g/dL),ogastro-intestinal bleeding,ochronic perianal disease (fistula, fissure),oabnormal white cell scanopositive ASCAofirst degree relative of a person suffering from IBD (only for subjects without known IBD), 3.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. 4.Patient or legal guardian agrees to sign the Informed Consent Form
Minimum age
10 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Patients with indeterminate colitis where the purpose is only to make a definitive diagnosis and where the inclusion criteria are not otherwise met2.Patient is known to suffer from intestinal obstruction (symptoms such as severe abdominal pain with accompanying nausea or vomiting)3.Definite stricture seen on SBFT 4.Patient had suspected GI stricture, a Given® Patency capsule was administered and Patient did not pass the Patency capsule. 5.Patient has a pacemaker or other implanted electro-medical device6.Patient has known history of small bowel Crohns disease7.Patient on treatment for active IBD 8.Patient with suspected celiac disease that has not been excluded 9.Patient on non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or higher) during the 3 months preceding enrolment10.Patient is pregnant11.Patient has any condition, which precludes compliance with study and/or device instructions, such as swallowing problems12.Patient suffers from life threatening conditions13.Patient is currently participating in another clinical study that may directly or indirectly affect the results of this study

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be randomized into two arms using the standard envelope procedure
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation generated by Matlab and the restriction method was by blocking
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 785 0
Commercial sector/Industry
Name [1] 785 0
Given Imaging Ltd
Country [1] 785 0
Israel
Primary sponsor type
Commercial sector/Industry
Name
Given Imaging Ltd., New Industrial Park, Yoqneam, Israel
Address
Country
Israel
Secondary sponsor category [1] 649 0
None
Name [1] 649 0
Nil
Address [1] 649 0
Country [1] 649 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2063 0
Royal Brisbane Hospital
Ethics committee address [1] 2063 0
Ethics committee country [1] 2063 0
Australia
Date submitted for ethics approval [1] 2063 0
Approval date [1] 2063 0
Ethics approval number [1] 2063 0
Ethics committee name [2] 2064 0
St Vincents Hospital Melbourne
Ethics committee address [2] 2064 0
Ethics committee country [2] 2064 0
Australia
Date submitted for ethics approval [2] 2064 0
Approval date [2] 2064 0
Ethics approval number [2] 2064 0
Ethics committee name [3] 2065 0
Royal Melbourne Hospital
Ethics committee address [3] 2065 0
Ethics committee country [3] 2065 0
Australia
Date submitted for ethics approval [3] 2065 0
Approval date [3] 2065 0
Ethics approval number [3] 2065 0
Ethics committee name [4] 2066 0
The Cabrini Medical Centre
Ethics committee address [4] 2066 0
Ethics committee country [4] 2066 0
Australia
Date submitted for ethics approval [4] 2066 0
Approval date [4] 2066 0
Ethics approval number [4] 2066 0
Ethics committee name [5] 2067 0
Maroondah Hospital, Eastern Health
Ethics committee address [5] 2067 0
Ethics committee country [5] 2067 0
Australia
Date submitted for ethics approval [5] 2067 0
Approval date [5] 2067 0
Ethics approval number [5] 2067 0
Ethics committee name [6] 2068 0
Repatriation General Hospital
Ethics committee address [6] 2068 0
Ethics committee country [6] 2068 0
Australia
Date submitted for ethics approval [6] 2068 0
Approval date [6] 2068 0
Ethics approval number [6] 2068 0
Ethics committee name [7] 2069 0
Sir Charles Gairdner Hospital
Ethics committee address [7] 2069 0
Ethics committee country [7] 2069 0
Australia
Date submitted for ethics approval [7] 2069 0
Approval date [7] 2069 0
Ethics approval number [7] 2069 0
Ethics committee name [8] 2070 0
Royal Prince Alfred Hospital
Ethics committee address [8] 2070 0
Ethics committee country [8] 2070 0
Australia
Date submitted for ethics approval [8] 2070 0
Approval date [8] 2070 0
Ethics approval number [8] 2070 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36271 0
Address 36271 0
Country 36271 0
Phone 36271 0
Fax 36271 0
Email 36271 0
Contact person for public queries
Name 9800 0
Melissa Cohen
Address 9800 0
Given Imaging Pty Ltd
Unit 4
Rydelink Business Park
277 Lane Cove Road
North Ryde NSW 2113
Country 9800 0
Australia
Phone 9800 0
+61 2 98893944
Fax 9800 0
+61 2 98893955
Email 9800 0
melissa@givenimaging.com
Contact person for scientific queries
Name 728 0
Melissa Cohen
Address 728 0
Given Imaging Pty Ltd
Unit 4
Rydelink Business Park
277 Lane Cove Road
North Ryde NSW 2113
Country 728 0
Australia
Phone 728 0
+61 2 98893944
Fax 728 0
+61 2 98893955
Email 728 0
melissa@givenimaging.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.