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

NCT06892990 | Recruiting

• 1 other identifier: COLORIZE
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Keywords

TXI; Inflammatory Bowel Diseases

Outcome Measures

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.

  up to 12 months

Study Arms (1)

TXI mode vs. WLE mode

EXPERIMENTAL

Use of TXI mode vs. WLE mode for evaluating the degree of inflammation during ileocolonoscopy. Both endoscopy modes are used during the same ileocolonoscopy on the same patient. Photo documentation is taken in both modes.

Diagnostic Test: TXI mode vs. WLE mode

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.

TXI mode vs. WLE mode

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ulm: lead

Study Sites (1)

Ulm University Hospital

Ulm, Baden-Wurttemberg, 89081, Germany

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Central Study Contacts

Benjamin Michael Walter, Prof. Dr. med.

CONTACT

+497315000; benjamin.walter@uniklinik-ulm.de

Anna Melzer, Dr. med.

CONTACT

anna.melzer@uniklinik-ulm.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department for Internal Medicine 1

Model Details: This is a single-group crossover study, as the two endoscopic light modes, TXI and WLE, are alternated within the same examination in the same patients.

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: March 25, 2025
• Study Start: May 8, 2024
• Primary Completion: March 31, 2025
• Study Completion: September 1, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)