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Endoscopy for Assessment of Mucosal Healing in IBD

NCT ID: NCT01417702

Last Updated: 2020-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

232 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-11-30

Brief Summary

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Inflammatory bowel disease (IBD) encompasses two major forms of chronic intestinal disorders, Crohn's disease and ulcerative colitis (UC). Diagnosis is based on several macroscopic and histologic features including patterns of inflammation, crypt abscesses and granulomas. i-Scan use an endoscopic image from the video processor and reconstruct virtual images in real time, resulting in an improved contrast of the capillary patterns and enhancement of the mucosal surface (so called virtual chromoendoscopy).

The main objective of this study is to determine endoscopic features of mucosal healing in patients with IBD and to compare these features to clinical and histological data in order to establish a new endoscopic classification of mucosal healing and to evaluate mucosal healing as a parameter of remission and relapse.

Detailed Description

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Conditions

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Crohn´s Disease Ulcerative Colitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Crohn´s disease - active

Patients in the active phase of the disease

High-definition white light endoscopy and i-Scan

Intervention Type DEVICE

Patients will undergo advanced endoscopic imaging. Findings will be compared to histopathological and clinical results.

Crohn´s disease - quiescent

Patients in the quiescent phase of the disease

High-definition white light endoscopy and i-Scan

Intervention Type DEVICE

Patients will undergo advanced endoscopic imaging. Findings will be compared to histopathological and clinical results.

Ulcerative colitis - active

Patients in the active phase of the disease

High-definition white light endoscopy and i-Scan

Intervention Type DEVICE

Patients will undergo advanced endoscopic imaging. Findings will be compared to histopathological and clinical results.

Ucerative colitis - quiescent

Patients in the quiescent phase of the disease

High-definition white light endoscopy and i-Scan

Intervention Type DEVICE

Patients will undergo advanced endoscopic imaging. Findings will be compared to histopathological and clinical results.

Interventions

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High-definition white light endoscopy and i-Scan

Patients will undergo advanced endoscopic imaging. Findings will be compared to histopathological and clinical results.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* Age 18-85 years
* Ability of subjects to understand character and individual consequences of clinical trial
* Subjects undergoing colonoscopy

Exclusion Criteria

* Inability to provide written informed consent
* Severe Coagulopathy (Prothrombin time \< 50% of control, Partial thromboplastin time \> 50 s)
* Pregnancy or breast feeding
* Active gastrointestinal bleeding
* Residing in institutions (e.g. prison)
* Proctocolectomy
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Helmut Neumann, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine I, University of Erlangen-Nuremberg, Germany

Markus F. Neurath, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine I, University of Erlangen-Nuremberg, Germany

Locations

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University of Erlangen-Nuremberg

Erlangen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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HN-0007

Identifier Type: -

Identifier Source: org_study_id