Ulcerative ColitisNCT00837304
Colon Capsule Endoscopy Versus Standard Colonoscopy in Ulcerative Colitis
An observational study of Ulcerative Colitis, run by University Hospital Muenster at 1 site in Germany.
Trial summary
The dimension of diagnostic procedures and therapy of chronic inflammatory bowel diseases largely depends on the degree of mucosal inflammation. Video colonoscopy is currently the gold standard in the evaluation of the mucosa in patients with Ulcerative Colitis (UC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- PillCam Colon Capsule and Standard Colonoscopy
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- How many people
- 14 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2009to Jul 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with known ulcerative colitis
Who may be able to join
- Patients over 18 years of age with
- known ulcerative colitis
- Indication for Standard Colonoscopy
- Informed Consent given by the patient
Who cannot join
- Patient has dysphagia
- Patient has congestive heart failure
- Patient has renal insufficiency
- Patient is known or is suspected to suffer from intestinal obstruction
- Patient has a cardiac pacemaker or other implanted electronical medical devices
- Patient is pregnant
Show all 9Show fewer
- Patient has had prior abdominal surgery of the GI tract
- Patient has any condition, which precludes compliance with study and/or device instructions.
- Age less than 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Colon Capsule Endoscopy Versus Standard Colonoscopy in Assessing Disease Activity in Patients With Ulcerative Colitis - A Prospective Trial
The dimension of diagnostic procedures and therapy of chronic inflammatory bowel diseases largely depends on the degree of mucosal inflammation. Video colonoscopy is currently the gold standard in the evaluation of the mucosa in patients with Ulcerative Colitis (UC). PillCam Colon Capsule was developed by Given Imaging, Israel, as possible alternative imaging modality to evaluate mucosal changes in patients with UC. The colonic mucosa can be visualized and recorded by video while the colon capsule passes the colon.
Many patients suffering from UC ask their physician for possible alternative diagnostic imaging because they are uncomfortable with conventional colonoscopy.
The primary aim of the present study is to compare the new Pillcam Colon Capsule with standard colonoscopy with respect to assessing mucosal disease activity and localization of inflamed colonic mucosa in patients with known UC.
- Conditions
- Ulcerative Colitis
- Being tested
- PillCam Colon Capsule, Standard Colonoscopy
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PillCam Colon CapsuleDevice
PillCam Colon Capsule: The PillCam Colon capsule has two cameras that enable the device to take video images from both ends. It is 31.11 mm in size and takes pictures at a rate of 4 frames per second. The delay mode allows recording of images from the esophagus and the stomach for 5 minutes before the capsule switches into sleep mode for 2 hours to save energy.
Standard ColonoscopyProcedure or surgery
Standard Colonoscopy: Pts. undergo colonoscopy with a video colonoscope (CF H180 AI; Olympus, Tokyo, Japan).
| Study group | Role | What they receive |
|---|---|---|
| UC | Patients with known ulcerative colitis Receives: Device: PillCam Colon Capsule; Procedure: Standard Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
a) disease activity of ulcerative colitis (modified Rachmilewitz score) b) extent of colonic manifestation of ulcerative colitis c) accuracy parameters (sensitivity, specificity)
Measured: 12 months
Secondary outcomes (1)
a) patient comfort b) detection of polyps c) differences in recognition of disease activity (physicians, nurses) d) differences in findings in the group of physicians (inter-observer differences)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tobias Meister, MD, Principal investigator, University of Muenster, Dept. of Medicine B
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837304
- Sponsor's protocol ID
- Med-B_CCE_vs_SC
- Status last verified
- Feb 2009
- First submitted
- 4 Feb 2009
- Last updated
- 10 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colon Capsule Endoscopy Versus Standard Colonoscopy in Assessing Disease Activity in Patients With Ulcerative Colitis - A Prospective Trial
- ClinicalTrials.gov ID
- NCT00837304
- Acronym / sponsor ID
- Med-B_CCE_vs_SC
- Conditions
- Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 5 Feb 2009 (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.
The dimension of diagnostic procedures and therapy of chronic inflammatory bowel diseases largely depends on the degree of mucosal inflammation. Video colonoscopy is currently the gold standard in the evaluation of the mucosa in patients with Ulcerative Colitis (UC). PillCam Colon Capsule was developed by Given Imaging, Israel, as possible alternative imaging modality to evaluate mucosal changes in patients with UC. The colonic mucosa can be visualized and recorded by video while the colon capsule passes the colon.
Many patients suffering from UC ask their physician for possible alternative diagnostic imaging because they are uncomfortable with conventional colonoscopy.
The primary aim of the present study is to compare the new Pillcam Colon Capsule with standard colonoscopy with respect to assessing mucosal disease activity and localization of inflamed colonic mucosa in patients with known UC.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UC | – | Device: PillCam Colon Capsule, Procedure: Standard ColonoscopyPatients with known ulcerative colitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with known ulcerative colitis
Key inclusion criteria (4 listed)
- Patients over 18 years of age with
- known ulcerative colitis
- Indication for Standard Colonoscopy
- Informed Consent given by the patient
Key exclusion criteria (9 listed)
- Patient has dysphagia
- Patient has congestive heart failure
- Patient has renal insufficiency
- Patient is known or is suspected to suffer from intestinal obstruction
- Patient has a cardiac pacemaker or other implanted electronical medical devices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PillCam Colon CapsulePillCam Colon Capsule: The PillCam Colon capsule has two cameras that enable the device to take video images from both ends. It is 31.11 mm in size and takes pictures at a rate of 4 frames per second. The delay mode allows recording of images from the esophagus and the stomach for 5 minutes before the capsule switches into sleep mode for 2 hours to save energy. | Device | UC |
| Standard ColonoscopyStandard Colonoscopy: Pts. undergo colonoscopy with a video colonoscope (CF H180 AI; Olympus, Tokyo, Japan). | Procedure or surgery | UC |
Primary outcome
a) disease activity of ulcerative colitis (modified Rachmilewitz score) b) extent of colonic manifestation of ulcerative colitis c) accuracy parameters (sensitivity, specificity)
Time frame: 12 months
1 secondary outcome
a) patient comfort b) detection of polyps c) differences in recognition of disease activity (physicians, nurses) d) differences in findings in the group of physicians (inter-observer differences)
Time frame: 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2012.
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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.
Tobias Meister, MD principal investigator
University of Muenster, Dept. of Medicine B
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by University Hospital Muenster at 1 site in Germany.
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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 10 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 was stopped early. Results are not available in the source record.
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?
a) disease activity of ulcerative colitis (modified Rachmilewitz score) b) extent of colonic manifestation of ulcerative colitis c) accuracy parameters (sensitivity, specificity) (time frame: 12 months). 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 10 Dec 2012.