IBDNCT07271264
A Randomised Paired Design Study of Texture and Colour Enhancement Imaging (TXI) Versus High-definition White Light Endoscopy
A study testing TXI in people with IBD, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- IBD
- What is being tested?
- TXI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Dec 2025to 30 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Central Middlesex Hospital
London, NW10 7NS
Landy, MRCP, PhD, 44 208965 5733, jonathan.landy@nhs.net
About this study
Official title: 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.
Read the 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.
- Conditions
- IBD
- Being tested
- TXI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TXIDiagnostic 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 group | Role | What they receive |
|---|---|---|
| TXI | Active comparator | Participants allocated to the "TXI" group undergo withdrawal using Texture and Colour Enhancement Imaging Receives: Diagnostic Test: TXI |
| White light | Other | Participants allocated in the "White light " group receive withdrawal with White light Receives: Diagnostic Test: TXI |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the proportion of patients with at least 1 dysplastic lesion detected using TXI compared with high-definition white light endoscopy.
The number of dysplastic areas detected during endoscopy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start8 Dec 2025
- Primary completion8 Dec 2028 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 219 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271264
- Sponsor's protocol ID
- RD25/051
- Status last verified
- Apr 2026
- First submitted
- 27 Nov 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Paired Design Study of Texture and Colour Enhancement Imaging (TXI) Versus High-definition White Light Endoscopy for Dysplasia Detection in IBD Surveillance.
- ClinicalTrials.gov ID
- NCT07271264
- Acronym / sponsor ID
- RD25/051
- Conditions
- IBD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 219 participants (estimated)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 8 Dec 2028 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TXI | Active comparator | Diagnostic Test: TXIParticipants allocated to the "TXI" group undergo withdrawal using Texture and Colour Enhancement Imaging |
| White light | Other | Diagnostic Test: TXIParticipants allocated in the "White light " group receive withdrawal with White light |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TXIParticipants 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. | Diagnostic test | TXI, White light |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TXI in people with IBD, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Landy, Consultant Gastroenterologist (020 8869 544, Jonathan.Landy@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.