Texture and Color Enhancement Imaging (TXI) for Inflammation Assessment in Patients With Inflammatory Bowel Diseases
Recruiting · NCT06892990 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Ulm
View the official record on ClinicalTrials.gov →Interventions studied
TXI mode vs. WLE mode
What this trial is about
In the context of the COLORIZE study, it is being tested whether the endoscopic light mode Texture and Color Enhancement Imaging (TXI) is non-inferior to the standard White Light Endoscopy (WLE) in assessing inflammatory activity in patients with Inflammatory Bowel Disease (IBD). For this purpose, ileocolonoscopy is performed on patients diagnosed with IBD, and standardized image documentation will be carried out in both WLE and TXI modes. Step biopsies are taken, and clinically validated, endoscopic, and histological scores are used.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Histologically confirmed inflammatory bowel disease (ulcerative colitis or Crohn\'s disease)
- Age ≥ 18 years
Exclusion criteria
- Post (procto-) colectomy
- Endoscopically impassable stenosis in the left hemi-colon
- ASA status \> 2 points
- BBPS \< 6 points (or \< 2 points per segment)
- Severe coagulation disorder
- Pregnancy, lactation
Where it is running
2 locations listed.
- Ulm University Hospital - Ulm, Baden-Wurttemberg, Germany
- Ulm University Hospital - Ulm, Baden-Wurttemberg, Germany