Crohn´s DiseaseNCT01102855
Endomicroscopy and Crohn´s Disease
An observational study of Crohn´s Disease, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
Purpose: The main objective of this study is to determine endomicroscopic features of Crohn´s disease. Background: Crohn´s disease is an inflammatory disease of the intestines that may affect any part of the gastrointestinal tract from anus to mouth, causing a wide variety of symptoms. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Crohn´s Disease
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2009to Aug 2011
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Crohn´s disease.
Who may be able to join
- Written informed consent
- Age 18-85 years
- Ability of subjects to understand character and individual consequences of clinical trial
- Subjects undergoing colonoscopy
Who cannot join
- Inability to provide written informed consent
- Severe Coagulopathy (Prothrombin time < 50% of control, Partial thromboplastin time > 50 s)
- Impaired renal function (Creatinine > 1.2 mg/dl)
- Pregnancy or breast feeding
- Active gastrointestinal bleeding
- Known allergy to fluorescein, acriflavin or cresyl violet
- Residing in institutions (e.g. prison)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Medicine I, University of Erlangen-Nuremberg
Erlangen, 91054
About this study
Official title: Confocal Laser Endomicroscopy in Patients With Crohn´s Disease
Purpose:
The main objective of this study is to determine endomicroscopic features of Crohn´s disease.
Background:
Crohn´s disease is an inflammatory disease of the intestines that may affect any part of the gastrointestinal tract from anus to mouth, causing a wide variety of symptoms. Diagnosis is based on several histologic features including transmural pattern of inflammation, crypt abscesses and granulomas. Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an "optical biopsy" of the gastrointestinal mucosa during the endoscopic procedure.
Scope:
In patients with Crohn´s disease.
Read the detailed description
Methods:
Patients underwent colonoscopy for the evaluation of Crohn´s disease. During the endoscopic procedure CLE will be performed.
Procedure:
The patient underwent colonoscopy. During the procedure the patient will receive intravenous fluorescein or topical mucosal staining with acriflavin or cresyl violet, followed by in-vivo CLE of the tissue. Confocal images are digitally saved and analyzed afterwards.
- Conditions
- Crohn´s Disease
- Medical subject headings
- Crohn Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine endomicroscopic features of Crohn´s disease.
Measured: October 2009 until May 2010
Secondary outcomes (1)
Comparison of CLE findings with conventional histology.
Measured: October 2009 until May 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startOct 2009
- Primary completionAug 2011
- Study completionAug 2011
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 Crohn´s DiseaseStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Investigators
- Markus F. Neurath, Study director, University of Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102855
- Sponsor's protocol ID
- HN-0002
- Status last verified
- Aug 2011
- First submitted
- 12 Apr 2010
- Last updated
- 11 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Neumann H, Vieth M, Atreya R, Grauer M, Siebler J, Bernatik T, Neurath MF, Mudter J. Assessment of Crohn's disease activity by confocal laser endomicroscopy. Inflamm Bowel Dis. 2012 Dec;18(12):2261-9. doi: 10.1002/ibd.22907. Epub 2012 Feb 16.
PubMed 22344873
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confocal Laser Endomicroscopy in Patients With Crohn´s Disease
- ClinicalTrials.gov ID
- NCT01102855
- Acronym / sponsor ID
- HN-0002
- Conditions
- Crohn´s Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 13 Apr 2010 (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.
Purpose:
The main objective of this study is to determine endomicroscopic features of Crohn´s disease.
Background:
Crohn´s disease is an inflammatory disease of the intestines that may affect any part of the gastrointestinal tract from anus to mouth, causing a wide variety of symptoms. Diagnosis is based on several histologic features including transmural pattern of inflammation, crypt abscesses and granulomas. Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an "optical biopsy" of the gastrointestinal mucosa during the endoscopic procedure.
Scope:
In patients with Crohn´s disease.
Detailed description
Methods:
Patients underwent colonoscopy for the evaluation of Crohn´s disease. During the endoscopic procedure CLE will be performed.
Procedure:
The patient underwent colonoscopy. During the procedure the patient will receive intravenous fluorescein or topical mucosal staining with acriflavin or cresyl violet, followed by in-vivo CLE of the tissue. Confocal images are digitally saved and analyzed afterwards.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Crohn´s disease.
Key inclusion criteria (4 listed)
- Written informed consent
- Age 18-85 years
- Ability of subjects to understand character and individual consequences of clinical trial
- Subjects undergoing colonoscopy
Key exclusion criteria (7 listed)
- Inability to provide written informed consent
- Severe Coagulopathy (Prothrombin time < 50% of control, Partial thromboplastin time > 50 s)
- Impaired renal function (Creatinine > 1.2 mg/dl)
- Pregnancy or breast feeding
- Active gastrointestinal bleeding
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 determine endomicroscopic features of Crohn´s disease.
Time frame: October 2009 until May 2010
1 secondary outcome
Comparison of CLE findings with conventional histology.
Time frame: October 2009 until May 2010
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 11 Aug 2011.
- Derived from this study: PubMed 22344873Neumann H, Vieth M, Atreya R, Grauer M, Siebler J, Bernatik T, Neurath MF, Mudter J. Assessment of Crohn's disease activity by confocal laser endomicroscopy. Inflamm Bowel Dis. 2012 Dec;18(12):2261-9. doi: 10.1002/ibd.22907. Epub 2012 Feb 16.
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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.
Markus F. Neurath study director
University of Erlangen-Nürnberg
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 Crohn´s Disease, 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 4 inclusion and 7 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 11 Aug 2011. 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?
To determine endomicroscopic features of Crohn´s disease. (time frame: October 2009 until May 2010). 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 NCT01102855, 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 11 Aug 2011.