Crohn´s DiseaseNCT01417715
Endomicroscopy for Assessment of Mucosal Healing
An observational study of Crohn´s Disease and Ulcerative Colitis, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
Inflammatory bowel disease (IBD) encompasses two major forms of chronic intestinal disorders, Crohn's disease and ulcerative colitis (UC). Diagnosis is based on several macroscopic and histologic features including patterns of inflammation, crypt abscesses and granulomas. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Crohn´s Disease, Ulcerative Colitis
- What is being tested?
- Endomicroscopy
- Type of treatment
- Medical device
- How many people
- 84 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2011to Aug 2014
- 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 and ulcerative colitis in the active and quiescent phase of the 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)
- Pregnancy or breast feeding
- Active gastrointestinal bleeding
- Residing in institutions (e.g. prison)
- Known allergy against fluorescein
- Proctocolectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Advanced Endoscopic Imaging Using Endomicroscopy for Assessment of Mucosal Healing in IBD
Inflammatory bowel disease (IBD) encompasses two major forms of chronic intestinal disorders, Crohn's disease and ulcerative colitis (UC). Diagnosis is based on several macroscopic and histologic features including patterns 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.
The main objective of this study is to determine endomicroscopic features of mucosal healing in patients with IBD.
- Conditions
- Crohn´s Disease, Ulcerative Colitis
- Being tested
- Endomicroscopy
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndomicroscopyDevice
Patients will undergo advanced endoscopic imaging using endomicroscopy. Findings will be compared to histopathological and clinical results.
| Study group | Role | What they receive |
|---|---|---|
| Crohn´s disease - active | Patients with Crohn´s disease in the active phase. Receives: Device: Endomicroscopy | |
| Crohn´s disease - quiescent | Patients with Crohn´s disease in the quiescent phase. Receives: Device: Endomicroscopy | |
| Ulcerative colitis - active | Patients with ulcerative colitis in the active stage. Receives: Device: Endomicroscopy | |
| Ucerative colitis - quiescent | Patients with ulcerative colitis in the quiescent stage. Receives: Device: Endomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucosal healing
We will determine endomicroscopic features of mucosal inflammation (e.g. goblet cell depletion, leackage, microvessel density) in IBD in order to establish a new endoscopic classification of mucosal healing.
Measured: up to three years
Secondary outcomes (2)
Histologic correlation
Comparison of clinical and histopathological data with endoscopic findings to evaluate mucosal healing as a parameter of remission and relapse in patients with IBD.
Measured: up to three years
Therapeutic effect
We will evaluate the effect of different therapeutic strategies (eg. anti-TNF treatment) on characteristics of mucosal healing (e.g. goblet cell depletion, microvessels, leakage).
Measured: up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionMay 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helmut Neumann, Professor, Principal investigator, Department of Medicine I, University of Erlangen-Nuremberg, GermanyMarkus F. Neurath, Professor, Principal investigator, Department of Medicine I, University of Erlangen-Nuremberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417715
- Sponsor's protocol ID
- HN-0008
- Status last verified
- Dec 2020
- First submitted
- 10 Aug 2011
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Endoscopic Imaging Using Endomicroscopy for Assessment of Mucosal Healing in IBD
- ClinicalTrials.gov ID
- NCT01417715
- Acronym / sponsor ID
- HN-0008
- Conditions
- Crohn´s Disease, Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Aug 2011 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 16 Aug 2011 (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.
Inflammatory bowel disease (IBD) encompasses two major forms of chronic intestinal disorders, Crohn's disease and ulcerative colitis (UC). Diagnosis is based on several macroscopic and histologic features including patterns 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.
The main objective of this study is to determine endomicroscopic features of mucosal healing in patients with IBD.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Crohn´s disease - active | – | Device: EndomicroscopyPatients with Crohn´s disease in the active phase. |
| Crohn´s disease - quiescent | – | Device: EndomicroscopyPatients with Crohn´s disease in the quiescent phase. |
| Ulcerative colitis - active | – | Device: EndomicroscopyPatients with ulcerative colitis in the active stage. |
| Ucerative colitis - quiescent | – | Device: EndomicroscopyPatients with ulcerative colitis in the quiescent stage. |
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 and ulcerative colitis in the active and quiescent phase of the 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)
- Pregnancy or breast feeding
- Active gastrointestinal bleeding
- Residing in institutions (e.g. prison)
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 |
|---|---|---|
| EndomicroscopyPatients will undergo advanced endoscopic imaging using endomicroscopy. Findings will be compared to histopathological and clinical results. | Device | Crohn´s disease - active, Crohn´s disease - quiescent, Ucerative colitis - quiescent, Ulcerative colitis - active |
Primary outcome
Mucosal healing
Time frame: up to three years
We will determine endomicroscopic features of mucosal inflammation (e.g. goblet cell depletion, leackage, microvessel density) in IBD in order to establish a new endoscopic classification of mucosal healing.
2 secondary outcomes
Histologic correlation
Time frame: up to three years
Therapeutic effect
Time frame: up to three 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 14 Dec 2020.
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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
Department of Medicine I, University of Erlangen-Nuremberg, Germany
Markus F. Neurath, Professor principal investigator
Department of Medicine I, University of Erlangen-Nuremberg, Germany
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 and Ulcerative Colitis, 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 14 Dec 2020. 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?
Mucosal healing (time frame: up to three years). 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 14 Dec 2020.