Texture and Color Enhancement Imaging (TXI) for Inflammation Assessment in Patients With Inflammatory Bowel Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Ulm
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed inflammatory bowel disease (ulcerative colitis or Crohn's disease)
Age ≥ 18 years
Disqualifiers
Post (procto-) colectomy
Endoscopically impassable stenosis in the left hemi-colon
ASA status > 2 points
BBPS < 6 points (or < 2 points per segment)
Trial design
Design model
Single group
Treatments tested in this trial
TXI mode vs. WLE mode
Diagnostic testExperimental use of TXI mode compared to standard use of WLE to assess inflammatory activity in patients with IBD during ileocolonoscopy. Both endoscopy modes are used during the same ileocolonoscopy on the same patient.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: TXI mode vs. WLE modeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Non-inferiority of the TXI mode in assessing the degree of inflammation in the correlation between endoscopic and histological scores.
Non-inferiority of the TXI mode compared to WLE assessing inflammation in the terminal ileum or neo-terminal ileum as well as in the colon is evaluated via endoscopic and histologic scores.
Time frame
up to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov