A Randomised Paired Design Study of Texture and Colour Enhancement Imaging (TXI) Versus High-definition White Light Endoscopy

Sponsor
London North West Healthcare NHS Trust
Study ID
NCT07271264
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TXI — DIAGNOSTIC_TEST
    Participants allocated to the "TXI" group undergo withdrawal using Texture and Colour Enhancement Imaging, while those in the "white light" group receive withdrawal with with high-definition white light endoscopy. Both procedures follow standardized protocols outlined in the study design.

Study Details

Texture and Colour Enhancement Imaging (TXI) improves texture, brightness, and colour in white-light endoscopy to highlight subtle tissue differences. Now available through the EVIS X1 system, early evidence suggests potential value in IBD. Studies show that TXI may help predict ulcerative colitis relapse and performs comparably to dye chromoendoscopy in detecting lesions, though no randomised data exist for dysplasia detection in IBD surveillance. We therefore propose a randomised paired study comparing TXI with high-definition white-light endoscopy for dysplasia detection in IBD surveillance.

Key Dates

Start date
Dec 8, 2025
Status verified
Apr 2026
Primary completion
Dec 8, 2028
Completion
Mar 30, 2029

Study Design

Enrollment
219 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: TXI
    Participants allocated to the "TXI" group undergo withdrawal using Texture and Colour Enhancement Imaging
  • Other: White light
    Participants allocated in the "White light " group receive withdrawal with White light

Primary Outcome Measure

To compare the proportion of patients with at least 1 dysplastic lesion detected using TXI compared with high-definition white light endoscopy. [ Time Frame: 6 months ]

Central Contacts

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