RecruitingNot ApplicableNCT06892990

Texture and Color Enhancement Imaging (TXI) for Inflammation Assessment in Patients With Inflammatory Bowel Diseases

Texture and Color Enhancement Imaging (TXI) for Real-time Prediction of Histologic Changes in Patients With Inflammatory Bowel Diseases: a Comparison of White Light Endoscopy (WLE) Versus TXI


Sponsor

University of Ulm

Enrollment

80 participants

Start Date

May 8, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria2

  • Histologically confirmed inflammatory bowel disease (ulcerative colitis or Crohn\'s disease)
  • Age ≥ 18 years

Exclusion Criteria6

  • 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

Interventions

DIAGNOSTIC_TESTTXI mode vs. WLE mode

Experimental 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.


Locations(1)

Ulm University Hospital

Ulm, Baden-Wurttemberg, Germany

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NCT06892990


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