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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01417702
Other study ID # HN-0007
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2011
Est. completion date November 2014

Study information

Verified date December 2020
Source University of Erlangen-Nürnberg Medical School
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 232
Est. completion date November 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Intervention

Device:
High-definition white light endoscopy and i-Scan
Patients will undergo advanced endoscopic imaging. Findings will be compared to histopathological and clinical results.

Locations

Country Name City State
Germany University of Erlangen-Nuremberg Erlangen

Sponsors (1)

Lead Sponsor Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mucosal healing We will determine high-definition white light endoscopic and i-Scan features of mucosal inflammation (e.g. erosions, erythema, ulcerous lesions) in IBD in order to establish a new endoscopic classification of mucosal healing. up to three years
Secondary Histologic correlation Comparison of clinical and histopathological data with endoscopic findings to evaluate mucosal healing as a parameter of remission and relapse. up to three years
Secondary Therapeutic effect We will evaluate the effect of different therapeutic strategies (eg. anti-TNF treatment) on characteristics (e.g. erosions, ulcers, erythema) of mucosal healing. up to three years
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