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Characterization of Crohn's Disease at Confocal Laser Endomicroscopy (CLE) and Related to Disease Activity

NCT01738529 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-02-18

No results posted yet for this study

Summary

A blinded prospective observation and methodology study with Confocal Laser Endomicroscopy (CLE) together with standard white light colonoscopy including inter- and intra-observation of patients with Crohn's disease.

Conditions

  • Crohn Disease

Interventions

DEVICE

CLE ileocolonoscopy

The patients enrolled including the control group, will be investigated respectively, by conventional colonoscopy and CLE in both the terminal ileum as colon. The degree and extent of Crohn's disease are assessed by conventional ileocolonoscopy (SI), CLE (selected parameters) and histology biopsies. Then, the correlation between histology (gold standard), SI and CLE is calculated. An intra-and inter-observer study follows on CLE parameters, where 3 observers are blinded with respect to each other. The pathologist is blinded to conventional and CLE parameters. CLE results are stratified in order to identify which of the recorded CLE parameters that correlate best with the two other methods.

Sponsors & Collaborators

  • Herlev Hospital

    lead OTHER

Principal Investigators

  • john g Karstensen, M.D. · Department of Gastroenterology

  • peter vilmann, Prof. · Department of Gastroenterology

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-10-31
Completion
2015-02-28

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01738529 on ClinicalTrials.gov