Using advanced imaging to assess inflammation in 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
This study is testing if a new imaging technique can help doctors better see inflammation in patients with Inflammatory Bowel Disease compared to the standard method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Ulm Academic / other |
| Locations | 1 site (Ulm, Baden-Wurttemberg) |
| Trial ID | NCT06892990 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Texture and Color Enhancement Imaging (TXI) compared to standard White Light Endoscopy (WLE) in assessing inflammation in patients with Inflammatory Bowel Disease (IBD). Patients diagnosed with IBD will undergo ileocolonoscopy, where images will be captured using both TXI and WLE modes. The study aims to determine if TXI provides a non-inferior assessment of inflammatory activity, which is crucial for making informed treatment decisions. Biopsies will be taken, and various scoring systems will be utilized to validate the findings.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed ulcerative colitis or Crohn's disease.
Not a fit: Patients who have undergone colectomy or have severe stenosis or coagulation disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate assessments of inflammation in IBD, improving treatment decisions and patient outcomes.
How similar studies have performed: While the use of advanced imaging techniques in endoscopy is gaining traction, this specific comparison of TXI to WLE in IBD assessment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ulm, Baden-Wurttemberg
- Ulm University Hospital — Ulm, Baden-Wurttemberg, Germany (Recruiting)
Study contacts
- Study coordinator: Benjamin Michael Walter, Prof. Dr. med.
- Email: benjamin.walter@uniklinik-ulm.de
- Phone: +497315000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.