Inflammatory Bowel DiseasesNCT02238665
CLE for Differential Diagnosis of IBD
An observational study of Inflammatory Bowel Diseases, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
Differential diagnosis between Ulcerative Colitis (UC) and Crohn's disease (CD) is of pivotal importance for the management of Inflammatory Bowel Disease (IBD) as both entities involve specific therapeutic management strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Endomicroscopy
- Type of treatment
- Medical device
- How many people
- 105 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2009to Sep 2014
- How long will I take part?
- 1 Day
- 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: Consecutive patients with well-established diagnosis of Crohn's disease and ulcerative colitis.
Who may be able to join
- equal or above 18 years of age
- ability to provide written informed consent
- well-established diagnosis of CD or UC
Who cannot join
- history of IBD reclassification in the last 3 years
- Boston Bowel Preparation Scale score's < 2 in at least one of the three broad regions of the colon (i.e. rectum plus left side colon, transverse colon plus left and right flexures, right colon)
- inability to provide written informed consent
- severe uncontrolled coagulopathy
- impaired renal function
- pregnancy or breast feeding
Show all 9Show fewer
- active gastrointestinal bleeding
- known allergy to fluorescein
- residence in institutions
Trial locations and contacts
1 site in 1 country.
About this study
Differential diagnosis between Ulcerative Colitis (UC) and Crohn's disease (CD) is of pivotal importance for the management of Inflammatory Bowel Disease (IBD) as both entities involve specific therapeutic management strategies. Confocal Laser Endomicroscopy (CLE) allows on demand in vivo characterization of architectural and cellular details during endoscopy. Here, we assessed the efficacy of CLE to differentiate between UC and CD.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Endomicroscopy
- 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.
EndomicroscopyDevice
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative colitis | Not described Receives: Device: Endomicroscopy | |
| Crohn's disease | Not described Receives: Device: Endomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with IBD
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startOct 2009
- Primary completionApr 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe 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
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helmut Neumann, University of Erlangen-Nürnberg Medical School
- Investigators
- Helmut Neumann, Professor, Principal investigator, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238665
- Sponsor's protocol ID
- HN-0005
- Status last verified
- Sep 2014
- First submitted
- 9 Sep 2014
- Last updated
- 12 Sep 2014
- Results posted
- No
Publications
Tontini GE, Mudter J, Vieth M, Atreya R, Gunther C, Zopf Y, Wildner D, Kiesslich R, Vecchi M, Neurath MF, Neumann H. Confocal laser endomicroscopy for the differential diagnosis of ulcerative colitis and Crohn's disease: a pilot study. Endoscopy. 2015 May;47(5):437-43. doi: 10.1055/s-0034-1391226. Epub 2014 Dec 18.
PubMed 25521573
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLE for Differential Diagnosis of IBD
- ClinicalTrials.gov ID
- NCT02238665
- Acronym / sponsor ID
- HN-0005
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Apr 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 12 Sep 2014 (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.
Differential diagnosis between Ulcerative Colitis (UC) and Crohn's disease (CD) is of pivotal importance for the management of Inflammatory Bowel Disease (IBD) as both entities involve specific therapeutic management strategies. Confocal Laser Endomicroscopy (CLE) allows on demand in vivo characterization of architectural and cellular details during endoscopy. Here, we assessed the efficacy of CLE to differentiate between UC and CD.
Study design
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ulcerative colitis | – | Device: Endomicroscopy |
| Crohn's disease | – | Device: Endomicroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with well-established diagnosis of Crohn's disease and ulcerative colitis.
Key inclusion criteria (3 listed)
- equal or above 18 years of age
- ability to provide written informed consent
- well-established diagnosis of CD or UC
Key exclusion criteria (9 listed)
- history of IBD reclassification in the last 3 years
- Boston Bowel Preparation Scale score's < 2 in at least one of the three broad regions of the colon (i.e. rectum plus left side colon, transverse colon plus left and right flexures, right colon)
- inability to provide written informed consent
- severe uncontrolled coagulopathy
- impaired renal function
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 |
|---|---|---|
| Endomicroscopy | Device | Crohn's disease, Ulcerative colitis |
Primary outcome
Number of participants with IBD
Time frame: 4 years
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 12 Sep 2014.
- Derived from this study: PubMed 25521573Tontini GE, Mudter J, Vieth M, Atreya R, Gunther C, Zopf Y, Wildner D, Kiesslich R, Vecchi M, Neurath MF, Neumann H. Confocal laser endomicroscopy for the differential diagnosis of ulcerative colitis and Crohn's disease: a pilot study. Endoscopy. 2015 May;47(5):437-43. doi: 10.1055/s-0034-1391226. Epub 2014 Dec 18.
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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.
Helmut Neumann, Professor principal investigator
University Hospital Erlangen
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 Inflammatory Bowel Diseases, run by University of Erlangen-Nürnberg Medical School 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 3 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: finished, as of the sponsor's last update on 12 Sep 2014. 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 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?
Number of participants with IBD (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02238665, which also lists 1 linked publication.
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 12 Sep 2014.