Inflammatory Bowel DiseasesMACCSNCT00434551
MACCS: Multicenter Australian CE in Patients With Suspected Crohn's Disease Study
An observational study of Inflammatory Bowel Diseases, run by Medtronic - MITG at 8 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- How many people
- 119 participants
- Where
- 8 sitesAustralia
- Study dates
- Feb 2005to Feb 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: clinics
Who may be able to join
- 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,
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Australia8 sites
Eastern Health
Box Hill, Victoria, 3128
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Repatriation General Hospital
Daw Park, South Australia, 5041
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Cabrini Medical Centre
Malvern, Victoria, 3144
Sir Charles Gardiner Hospital
Nedlands, Western Australia, 6009
Royal Melbourne Hospital
Parkville, Victoria, 3050
About this study
Official title: Evaluation of Capsule Endoscopy in Patients With Suspected Small Bowel Crohn's Disease
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.
Read the 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, disposable video camera that transmits high quality images of the small intestinal mucosa. This enables the small intestine to be readily accessible to physicians investigating for the presence of small bowel disorders such as Crohn's disease. It has been demonstrated that capsule endoscopy identifies Crohn's disease when other methods are not helpful. Diagnostic yields of 70% have been reported in small series of studies performed in suspected small bowel Crohn's disease.
This study is designed to determine the accuracy and clinical impact of Capsule Endoscopy in detecting suspected small Bowel Crohn's Disease whose initial evaluation was non-diagnostic. It will also serve to better understand the impact of capsule endoscopy on the natural history of the disorder.
Patients will be randomized to undergo capsule endoscopy either one week or five weeks after enrolment. This will allow assessment of the natural history of this form of Crohn's disease and ensure that any changes in CDAI and QOL after capsule endoscopy are not merely a result of this natural history.
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- small bowel Crohn's disease, capsule endoscopy, PillCam SB, Patients with suspected small bowel Crohn's disease
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with suspected Crohn's disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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.
Measured: end of study
Secondary outcomes (1)
• To assess the clinical impact made by CE in patients with clinically suspected small bowel Crohn's disease
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2007 (estimated)
- Study startFeb 2005
- Primary completionDec 2007
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Warwick Selby, MD, Principal investigator, Royal Prince Alfred Hospital, Sydney, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00434551
- Sponsor's protocol ID
- MA-36
- Acronym
- MACCS
- Status last verified
- Feb 2007
- First submitted
- 11 Feb 2007
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Capsule Endoscopy in Patients With Suspected Small Bowel Crohn's Disease
- ClinicalTrials.gov ID
- NCT00434551
- Acronym / sponsor ID
- MACCS / MA-36
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- small bowel Crohn's disease, capsule endoscopy, PillCam SB, Patients with suspected small bowel Crohn's disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 13 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, disposable video camera that transmits high quality images of the small intestinal mucosa. This enables the small intestine to be readily accessible to physicians investigating for the presence of small bowel disorders such as Crohn's disease. It has been demonstrated that capsule endoscopy identifies Crohn's disease when other methods are not helpful. Diagnostic yields of 70% have been reported in small series of studies performed in suspected small bowel Crohn's disease.
This study is designed to determine the accuracy and clinical impact of Capsule Endoscopy in detecting suspected small Bowel Crohn's Disease whose initial evaluation was non-diagnostic. It will also serve to better understand the impact of capsule endoscopy on the natural history of the disorder.
Patients will be randomized to undergo capsule endoscopy either one week or five weeks after enrolment. This will allow assessment of the natural history of this form of Crohn's disease and ensure that any changes in CDAI and QOL after capsule endoscopy are not merely a result of this natural history.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with suspected Crohn's disease |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- clinics
Key inclusion criteria (15 listed)
- 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):
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
• 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.
Time frame: end of study
1 secondary outcome
• To assess the clinical impact made by CE in patients with clinically suspected small bowel Crohn's disease
Time frame: end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Warwick Selby, MD principal investigator
Royal Prince Alfred Hospital, Sydney, Australia
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Medtronic - MITG at 8 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• 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. (time frame: end of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.