Eosinophilic EsophagitisNCT01234376
Confocal Laser Endomicroscopy in Patients With Eosinophilic Esophagitis
An observational study of Eosinophilic Esophagitis, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
Confocal laser endomicroscopy enables in vivo microscopic imaging within the mucosa layer of the gut at a subcellular resolution. Various studies have addressed the potential of endomicroscopy for the in vivo diagnosis of esophageal squamous cell carcinoma, Barrett´s esophagus and esophageal adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Confocal laser endomicroscopy
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2010to Dec 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with eosinophilic esophagitis who underwent EGD for the evaluation of their symptoms. Control patients who underwent EGD because of other reasons.
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 EGD
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.
About this study
Confocal laser endomicroscopy enables in vivo microscopic imaging within the mucosa layer of the gut at a subcellular resolution. Various studies have addressed the potential of endomicroscopy for the in vivo diagnosis of esophageal squamous cell carcinoma, Barrett´s esophagus and esophageal adenocarcinoma. Currently, there is only one case report from our group who noted the utility of endomicroscopy for the in vivo diagnosis of eosinophilic esophagitis.
The purpose of this study is to determine whether endomicroscopy is effective for the in vivo diagnosis of eosinophilic esophagitis.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Confocal laser endomicroscopy
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confocal laser endomicroscopyDevice
Confocal laser endomicroscopy
| Study group | Role | What they receive |
|---|---|---|
| Control patients | Not described Receives: Device: Confocal laser endomicroscopy | |
| Patients with eosinophilic esophagitis | Not described Receives: Device: Confocal laser endomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of endomicroscopy for the in vivo diagnosis of eosinophilic esophagitis
Measured: November 2010 - November 2012
Secondary outcomes (1)
Differentiation of mucosal alterations in patients with eosinophilic esophagitis compared to patients with gastroesophageal reflux disease.
Measured: November 2010 - November 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus F. Neurath, M.D., Ph.D., Study director, University of Erlangen-NürnbergHelmut Neumann, M.D., Ph.D., Principal investigator, University of Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234376
- Sponsor's protocol ID
- HN-0003
- Status last verified
- Dec 2020
- First submitted
- 2 Nov 2010
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
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
- Confocal Laser Endomicroscopy in Patients With Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT01234376
- Acronym / sponsor ID
- HN-0003
- Conditions
- Eosinophilic Esophagitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Nov 2010 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Nov 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.
Confocal laser endomicroscopy enables in vivo microscopic imaging within the mucosa layer of the gut at a subcellular resolution. Various studies have addressed the potential of endomicroscopy for the in vivo diagnosis of esophageal squamous cell carcinoma, Barrett´s esophagus and esophageal adenocarcinoma. Currently, there is only one case report from our group who noted the utility of endomicroscopy for the in vivo diagnosis of eosinophilic esophagitis.
The purpose of this study is to determine whether endomicroscopy is effective for the in vivo diagnosis of eosinophilic esophagitis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control patients | – | Device: Confocal laser endomicroscopy |
| Patients with eosinophilic esophagitis | – | Device: Confocal laser endomicroscopy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with eosinophilic esophagitis who underwent EGD for the evaluation of their symptoms. Control patients who underwent EGD because of other reasons.
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 EGD
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Confocal laser endomicroscopyConfocal laser endomicroscopy | Device | Control patients, Patients with eosinophilic esophagitis |
Primary outcome
Effectiveness of endomicroscopy for the in vivo diagnosis of eosinophilic esophagitis
Time frame: November 2010 - November 2012
1 secondary outcome
Differentiation of mucosal alterations in patients with eosinophilic esophagitis compared to patients with gastroesophageal reflux disease.
Time frame: November 2010 - November 2012
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.
Markus F. Neurath, M.D., Ph.D. study director
University of Erlangen-Nürnberg
Helmut Neumann, M.D., Ph.D. principal investigator
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 Eosinophilic Esophagitis, 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?
Effectiveness of endomicroscopy for the in vivo diagnosis of eosinophilic esophagitis (time frame: November 2010 - November 2012). 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.