- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07271264
A Randomised Paired Design Study of Texture and Colour Enhancement Imaging (TXI) Versus High-definition White Light Endoscopy
April 7, 2026 updated by: London North West Healthcare NHS Trust
A Randomised Paired Design Study of Texture and Colour Enhancement Imaging (TXI) Versus High-definition White Light Endoscopy for Dysplasia Detection in IBD Surveillance.
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.
Study Overview
Detailed Description
Texture and colour enhancement imaging (TXI) is designed to enhance texture, brightness and colour in white light in order to clearly define subtle tissue differences.
This has been shown to enhance subtle tissue differences (20).
This technology has recently become available in routine clinical practice with introduction of the EVIS X1 system (Olympus).
Some promising data about the use of TXI in IBD are emerging.
In a prospective observational study, 146 UC patients in endoscopic remission were evaluated with WLE and TXI.
Patients with accentuated redness and poor visibility of deep vessels at TXI had significantly lower UC relapse-free rates than patients with no redness or accentuated redness alone, suggesting a possible role of TXI in guiding treatment intensification (21).
In a small study of 16 IBD patients undergoing surveillance colonoscopy, TXI missed no lesions detected by subsequent dye chromoendoscopy (22).
There are no randomised data regarding the utility of TXI for detection of dysplasia in colonoscopy IBD surveillance.
We propose to undertake a randomised paired design study of Texture and Colour Enhancement Imaging (TXI) versus high-definition white light endoscopy for dysplasia detection in IBD surveillance.
Study Type
Interventional
Enrollment (Estimated)
219
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jonathan Landy, Consultant Gastroenterologist
- Phone Number: 020 8869 544
- Email: Jonathan.Landy@nhs.net
Study Locations
-
-
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London, United Kingdom, NW10 7NS
- Recruiting
- Central Middlesex Hospital
-
Contact:
- Landy, MRCP, PhD
- Phone Number: 44 208965 5733
- Email: jonathan.landy@nhs.net
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients >16 with inflammatory bowel disease undergoing surveillance colonoscopy.
- Patients with Crohn's (L2/L3 Montreal classification) with >50% colonic involvement OR
- Patients with ulcerative colitis with Extensive or left sided disease (E3 or E2 Montreal classification) for at least 8 years or a diagnosis of Primary sclerosing cholangitis concomitant with IBD.
Exclusion Criteria:
- Disease duration <8 years unless a diagnosis of PSC
- Incomplete colonoscopy
- BBPS <6 or <2 in any segment
- MES ≥2 or any variable of the SES-CD is ≥2 or any stenosis for >10cm segment (above the rectum)
- Previous colorectal resection
- Thrombocytopaenia (platelet count <50) or Coagulopathy precluding biopsy
- Anticoagulation that has not been held appropriately prior to the procedure (must be held at least the morning of the procedure).
- Pregnancy
- Unable or unwilling to consent to study participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: TXI
Participants allocated to the "TXI" group undergo withdrawal using Texture and Colour Enhancement Imaging
|
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.
|
|
Other: White light
Participants allocated in the "White light " group receive withdrawal with White light
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
The number of dysplastic areas detected during endoscopy
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 8, 2025
Primary Completion (Estimated)
December 8, 2028
Study Completion (Estimated)
March 30, 2029
Study Registration Dates
First Submitted
November 27, 2025
First Submitted That Met QC Criteria
November 27, 2025
First Posted (Actual)
December 9, 2025
Study Record Updates
Last Update Posted (Actual)
April 13, 2026
Last Update Submitted That Met QC Criteria
April 7, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- RD25/051
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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