Skip to main content
OpenTrials
Completed

NCT Number: NCT03536091

Magnification Endoscopy and Electronic Chromoendoscopy in Patients With Inflammatory Bowel Disease

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Erlangen

Erlangen, 91054, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnification endoscopy

Diagnostic Test

All IBD patients will undergo magnification endoscopy with 136-fold optical magnification in conjunction with optical chromoendoscopy

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 24, 2018
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.