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Endomicroscopy in Ulcerative Colitis

NCT00659867 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2016-09-27

No results posted yet for this study

Summary

This is a confirmatory, multicentric, prospective, randomized, controlled, single-blind study in subjects with long standing ulcerative colitis in clinical remission with indication for surveillance colonoscopy. The patients are examined with the PENTAX EC-3870CIFK and EC-3870CILK confocal colonoscopes either by chromoscopy-guided endomicroscopy with targeted biopsies or by standard endoscopy with random and targeted biopsies. The aim is to investigate whether chromoscopy-guided endomicroscopy has a higher sensitivity than standard endoscopy with respect to detection of intraepithelial neoplasia (IN) and to compare the proportion of patients with at least 1 IN detected by chromoscopy-guided endomicroscopy versus standard endoscopy.

Conditions

Interventions

DEVICE

PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes

chromoscopy-guided endomicroscopy with targeted biopsies

DEVICE

PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes

Standard endoscopy with random and targeted biopsies

Sponsors & Collaborators

  • Johannes Gutenberg University Mainz

    collaborator OTHER

  • PENTAX Europe GmbH

    lead INDUSTRY

Principal Investigators

  • Ralf Kiesslich, Prof. Dr. · Johannes Gutenberg-Universität Mainz, I. Med. Klinik

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2015-07-31
Completion
2016-09-30

Countries

  • Germany
  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT00659867 on ClinicalTrials.gov