IBDTXIorDyENCT07208214
Texture and Colour Enhancement Imaging (TXI) Versus Dye Chromoendoscopy for Dysplasia Detection in IBD Surveillance.
A study testing TXI in people with IBD, run by London North West Healthcare NHS Trust.
Trial summary
In individuals with inflammatory bowel disease (IBD), bowel cancer can develop from abnormal cell changes (dysplasia). Regular colonoscopies are recommended to identify these early changes, which can be difficult to detect because they are often small and subtle. Read more about this study
- Who is it for?
- Ages 18 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
- 242 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Jul 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- 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
- 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
- The participant may not enter the study if ANY of the following apply:
- 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
Show all 11Show fewer
- 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).
- Allergy to Indigo Carmine
- Pregnancy
- Unable or unwilling to consent to study participation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomised Parallel-group Study of Texture and Colour Enhancement Imaging (TXI) Versus Dye Chromoendoscopy for Dysplasia Detection in IBD Surveillance.
In individuals with inflammatory bowel disease (IBD), bowel cancer can develop from abnormal cell changes (dysplasia). Regular colonoscopies are recommended to identify these early changes, which can be difficult to detect because they are often small and subtle. Dye-based imaging has been used to improve detection, but it requires additional preparation and time. Texture and Colour Enhancement Imaging (TXI) is a newer method available in clinical practice that adjusts brightness, colour, and texture on high-definition cameras. This study will compare TXI with dye-based imaging to assess which approach detects precancerous changes more effectively in patients with IBD.
Read the detailed description
Bowel cancer in individuals with inflammatory bowel disease (IBD) often develops from abnormal changes in the cells lining the bowel, known as dysplasia. International guidelines recommend undertaking regular colonoscopies to check for precancerous changes in patients with IBD. In the past, these precancerous changes were thought to be invisible, but with improved camera imaging technology, most cases of early changes can now be detected. However, early precancerous changes remain difficult to identify because they often appear as small, flat, and subtle lesions.
Studies have shown that applying dye to the bowel lining during colonoscopy can improve the detection of early changes compared with standard endoscopy. Nevertheless, the use of dye presents challenges, including additional preparation, longer procedure time, and the need for specific training. Newer high-definition cameras have demonstrated higher detection rates than older standard cameras. Advances in imaging technology have also led to the development of novel techniques designed to improve detection and identification of abnormal tissues. One such technique is Texture and Colour Enhancement Imaging (TXI), which enhances texture, brightness, and colour in high-definition cameras, making small and subtle differences in tissue more visible. This technology is now available in routine clinical practice with the EVIS X1 system (Olympus).
No randomized studies have yet evaluated the effectiveness of TXI in detecting early precancerous changes during colonoscopy in patients with IBD. The present study is designed to compare TXI with dye-based imaging in order to determine which method more effectively detects precancerous changes in IBD.
- 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 "Dye" group receive withdrawal with Dye chromoendoscopy. 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 |
| Dye | Other | Participants allocated in the "Dye" group receive withdrawal with Dye chromoendoscopy. 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 dye chromoendoscopy
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 posted6 Oct 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (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
- 242 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
- NCT07208214
- Sponsor's protocol ID
- RD24/053
- Acronym
- TXIorDyE
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 6 Oct 2025
- 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 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Parallel-group Study of Texture and Colour Enhancement Imaging (TXI) Versus Dye Chromoendoscopy for Dysplasia Detection in IBD Surveillance.
- ClinicalTrials.gov ID
- NCT07208214
- Acronym / sponsor ID
- TXIorDyE / RD24/053
- Conditions
- IBD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 6 Oct 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.
In individuals with inflammatory bowel disease (IBD), bowel cancer can develop from abnormal cell changes (dysplasia). Regular colonoscopies are recommended to identify these early changes, which can be difficult to detect because they are often small and subtle. Dye-based imaging has been used to improve detection, but it requires additional preparation and time. Texture and Colour Enhancement Imaging (TXI) is a newer method available in clinical practice that adjusts brightness, colour, and texture on high-definition cameras. This study will compare TXI with dye-based imaging to assess which approach detects precancerous changes more effectively in patients with IBD.
Detailed description
Bowel cancer in individuals with inflammatory bowel disease (IBD) often develops from abnormal changes in the cells lining the bowel, known as dysplasia. International guidelines recommend undertaking regular colonoscopies to check for precancerous changes in patients with IBD. In the past, these precancerous changes were thought to be invisible, but with improved camera imaging technology, most cases of early changes can now be detected. However, early precancerous changes remain difficult to identify because they often appear as small, flat, and subtle lesions.
Studies have shown that applying dye to the bowel lining during colonoscopy can improve the detection of early changes compared with standard endoscopy. Nevertheless, the use of dye presents challenges, including additional preparation, longer procedure time, and the need for specific training. Newer high-definition cameras have demonstrated higher detection rates than older standard cameras. Advances in imaging technology have also led to the development of novel techniques designed to improve detection and identification of abnormal tissues. One such technique is Texture and Colour Enhancement Imaging (TXI), which enhances texture, brightness, and colour in high-definition cameras, making small and subtle differences in tissue more visible. This technology is now available in routine clinical practice with the EVIS X1 system (Olympus).
No randomized studies have yet evaluated the effectiveness of TXI in detecting early precancerous changes during colonoscopy in patients with IBD. The present study is designed to compare TXI with dye-based imaging in order to determine which method more effectively detects precancerous changes in IBD.
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 |
| Dye | Other | Diagnostic Test: TXIParticipants allocated in the "Dye" group receive withdrawal with Dye chromoendoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients >16 with inflammatory bowel disease undergoing surveillance colonoscopy.
Key exclusion criteria (11 listed)
- The participant may not enter the study if ANY of the following apply:
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 "Dye" group receive withdrawal with Dye chromoendoscopy. Both procedures follow standardized protocols outlined in the study design. | Diagnostic test | Dye, TXI |
Primary outcome
To compare the proportion of patients with at least 1 dysplastic lesion detected using TXI compared with dye chromoendoscopy
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 6 Oct 2025.
- 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.
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.
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 11 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: opening soon, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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 dye chromoendoscopy (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 6 Oct 2025.