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Confocal Laser Endomicroscopy for Assessment of Mucosal Healing in Ulcerative Colitis

NCT02676817 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2016-02-08

No results posted yet for this study

Summary

The aim of the study is to construct and validate an endomicroscopic score correlated with microscopic inflammation activity in patients with UC.

Probe-based confocal laser endomicroscopy (pCLE) is a new endoscopic imaging modality, which offers the possibility to perform in vivo mucosal microscopic analysis in real time during endoscopy.

Primary Objectives : Development and validation of a UC endomicroscopic score, after correlation between pCLE data and histological data using the Geboes' score as a gold standard during ulcerative colitis.

Secondary Objectives:

* Identify predictive factors for the response to adalimumab.
* Identify predictive factors for recurrence in patients with UC in remission (Mayo score 0 or 1).
* Safety of the pCLE procedure

Conditions

  • Colitis, Ulcerative

Sponsors & Collaborators

  • European Georges Pompidou Hospital

    lead OTHER

Principal Investigators

  • gabriel rahmi, MD · European Georges Pompidou Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-02-29
Completion
2017-02-28

Countries

  • France

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 NCT02676817 on ClinicalTrials.gov