Texture and Color Enhancement Imaging (TXI) for Inflammation Assessment in Patients With Inflammatory Bowel Diseases
Not applicable · Testing TXI mode vs. WLE mode · 1 site · University of Ulm
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing TXI mode vs. WLE mode (a diagnostic test) as a way to diagnose or measure disease. Condition(s) listed: Inflammatory Bowel Diseases, Colitis, Ulcerative and Crohn Disease.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Histologically confirmed inflammatory bowel disease (ulcerative colitis or Crohn\'s disease)
- Age ≥ 18 years
There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 80 participants are expected to take part.
- Start date: 2024-05-08.
- Main results expected around 2025-03-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Germany.
Main thing being measured
- Non-inferiority of the TXI mode in assessing the degree of inflammation in the correlation between endoscopic and histological scores. (up to 12 months)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease |
| Lead sponsor | University of Ulm |
| Enrollment | 80 (estimated) |
| Start date | 2024-05-08 |
| Primary completion (est.) | 2025-03-31 |
| First posted | 2025-03-25 |
| Last updated | 2025-05-02 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT06892990 |
Interventions
- TXI mode vs. WLE mode (Diagnostic Test)
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.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Ulm University Hospital | Ulm, Baden-Wurttemberg | Germany | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.