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Magnification Endoscopy and Electronic Chromoendoscopy in Patients With Inflammatory Bowel Disease

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ClinicalTrials.gov Identifier: NCT03536091
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Timo Rath, University of Erlangen-Nürnberg Medical School

Brief Summary:
In this study the investigators aim to evaluate the ability of i-scan OE together with magnification endoscopy to detect and assess microscopic inflammation in patients with inflammator bowel diseases (IBD).

Condition or disease Intervention/treatment
Inflammatory Bowel Diseases Diagnostic Test: Magnification endoscopy

Detailed Description:
In this study the investigators aim to evaluate the ability of i-scan OE together with magnification endoscopy to detect and assess microscopic inflammation in patients with inflammator bowel diseases. For this purpose, IBD patients will be prospectively enrolled and inflammatory changes will be assessed using optical magnification endoscopy in conjunction with optical chromoendoscopy. Endoscopic scoring of inflammatory changes in IBD patients will be done on a newly developed magnification score resulting as a consensus from experts in optical diagnosis and endoscopy in IBD patients. Results will be correlated against histopathology.

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Magnification Endoscopy and Electronic Chromoendoscopy in Patients With Inflammatory Bowel Disease
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy


Intervention Details:
  • Diagnostic Test: Magnification endoscopy
    All IBD patients will undergo magnification endoscopy with 136-fold optical magnification in conjunction with optical chromoendoscopy


Primary Outcome Measures :
  1. Assessment of endoscopic Inflammation [ Time Frame: 12 months ]
    Endoscopic Inflammation will be determined and scored by assessement of the vascular and mucosal pattern under magnification endoscopy.

  2. Assessment of histopathological Inflammation [ Time Frame: 12 months ]
    Histopathologic Inflammation will be assessed by grading inflammation of intestinal biopsies routinely obtained during colonoscopy on established pathological scores.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
IBD patients treated in the outpatient department of the University Hospital Erlangen
Criteria

Inclusion Criteria:

  • Patients with established diagnosis of Inflammatory Bowel Diseases
  • Ability to provide written informed consent
  • Age 18 years and older

Exclusion Criteria:

  • poor bowel preparation
  • inability to provide written informed consent
  • minors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536091


Contacts
Contact: Timo Rath 49 9131 ext 8545041 timo.rath@uk-erlangen.de

Locations
Germany
University Hospital Erlangen Recruiting
Erlangen, Germany, 91054
Contact: Timo Rath, Professor of Endoscopy    49 9131 ext 85 45041    timo.rath@uk-erlangen.de   
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School

Responsible Party: Timo Rath, Professor of Endoscopy and Molecular Imaging, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT03536091     History of Changes
Other Study ID Numbers: EREN IBD
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis