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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03464474
Other study ID # 2017-476-f-S
Secondary ID
Status Recruiting
Phase N/A
First received March 7, 2018
Last updated March 22, 2018
Start date April 1, 2018
Est. completion date October 1, 2019

Study information

Verified date March 2018
Source University Hospital Muenster
Contact Dominik Bettenworth, Professor, MD
Phone +492518357935
Email dominik.bettenworth@ukmuenster.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Ulcerative colitis (UC) belongs to the group of inflammatory bowel disease (IBD) and is characterized by a chronic relapsing disease course. As uncontrolled intestinal inflammation can lead to severe disease complications, treatment of UC has evolved from sole treatment of symptoms up to histological remission which is marked by the absence of histological inflammation. To correctly assess and quantify the degree of histological inflammation in IBD patients remains difficult.

Digital holographic microscopy (DHM) is a new imaging technique belonging to quantitative phase contrast imaging. It is based on the detection of optical path-length delays in a stain-free manner, thereby providing a refractive index which directly correlates to tissue density.

This study aims to evaluate the role of DHM for quantifying the degree of histological inflammation in endoscopically acquired biopsies of UC patients in a prospective clinical trial. From 28 UC patients, the investigators will obtain endoscopically acquired colonic biopsies. The investigators will assess the degree of inflammation in these biopsies using DHM and in addition to this an experienced histopathologist will determine the degree of inflammation in these biopsies using a histological scoring system (Nancy-Score = goldstandard). Finally, the investigators will directly correlate the results from DHM analysis to the histological analysis using the Nancy-Score.


Recruitment information / eligibility

Status Recruiting
Enrollment 28
Est. completion date October 1, 2019
Est. primary completion date April 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with an indication for a colonoscopy

Exclusion Criteria:

- Patients under 18 years, pregnancy

- Inability to have a patient education

- Bad conditions or other reasons prohibiting a colonoscopy

Study Design


Intervention

Device:
digital holographic microscopy
Colonic biopsies from all patients will be assessed using digital holographic microscopy in comparison to the existing Goldstandard (histopathological analysis).

Locations

Country Name City State
Germany Unversity Clinic Muenster Münster

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Analysis of the inflammation grade of mucosal biopsies of ulcerative colitis patients From patients with ulcerative colitis, the investigators will collect endoscopically acquired colonic biopsies. For the primary outcome, the investigators will correlate the conventional histological analysis using an established histological scoring system (Nancy-Score) in comparison to the experimental procedure using digital holographic microscopy thereby determining a refractive index which directly correlates to tissue density. Endoscopically acquired biopsies will immediately be transported to the laboratory. After processing, biopsies can be used for histological assessment and for digital holographic microscopy; biopsies will be assessed within a time period up to 56 weeks.
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