Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Magnification Endoscopy and Electronic Chromoendoscopy in Patients With Inflammatory Bowel Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03536091
Recruitment Status : Completed
First Posted : May 24, 2018
Last Update Posted : September 26, 2019
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.

Layout table for study information
Study Type : Observational
Actual 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
Actual Primary Completion Date : June 1, 2018
Actual 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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


Locations
Layout table for location information
Germany
University Hospital Erlangen
Erlangen, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Layout table for additonal information
Responsible Party: Timo Rath, Professor of Endoscopy and Molecular Imaging, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT03536091    
Other Study ID Numbers: EREN IBD
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis