Inflammatory Bowel DiseasesNCT06266104
Image Enhanced Endoscopy IBD
A study testing Image Enhanced Endoscopy Filters in people with Inflammatory Bowel Diseases and Dysplasia, run by Royal Perth Hospital at 1 site in Australia.
Trial summary
Dye- spray chromoendoscopy remains the recommended gold standard approach for IBD dysplasia surveillance colonoscopy however recently published European and American guidelines recommend either dye-spray or virtual chromoendoscopy can be used for surveillance. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, Dysplasia
- What is being tested?
- Image Enhanced Endoscopy Filters
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 1 siteAustralia
- Study dates
- 3 Apr 2024to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with inflammatory bowel disease aged 18 to 75 years, that meet Australian recommendations to undergo surveillance colonoscopy will be identified and invited participate in the study.
Who cannot join
- Any active disease
- Inadequate bowel preparation
- Previous surgical resection involving the colon
- History of bowel cancer
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Royal Perth Hosptial
Perth, Western Australia, 6000
Sherman Picardo, MBBS, 92242244
About this study
Official title: Image Enhanced Endoscopy Technology to Improve the Detection of Colorectal Dysplasia in Patients With Inflammatory Bowel Disease
Dye- spray chromoendoscopy remains the recommended gold standard approach for IBD dysplasia surveillance colonoscopy however recently published European and American guidelines recommend either dye-spray or virtual chromoendoscopy can be used for surveillance. The newer Imaged Enhanced Endoscopy technologies TXI and LCI have not formally been evaluated in IBD surveillance in a randomised controlled trial setting. These modes can easily be applied during colonoscopy and if demonstrated to be effective may save time and eliminate the need for dye-spray chromoendoscopy in the future.
- Conditions
- Inflammatory Bowel Diseases, Dysplasia
- Being tested
- Image Enhanced Endoscopy Filters
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image Enhanced Endoscopy FiltersProcedure or surgery
Patients that undergoing surveillance and consent to be involved in the study will be randomised to undergo surveillance with LCI, TXI or dye-spray chromoendoscopy (methylene blue).
| Study group | Role | What they receive |
|---|---|---|
| Dye Spray Chromoendoscopy | Placebo comparator | Patients undergoing surveillance with dye spray chromoendoscopy Receives: Procedure: Image Enhanced Endoscopy Filters |
| TXI | Active comparator | Patients undergoing surveillance with TXI (Texture and Colour Enhancement Imaging) Receives: Procedure: Image Enhanced Endoscopy Filters |
| LCI | Active comparator | Patients undergoing surveillance with LCI (Linked Colour Imaging ) Receives: Procedure: Image Enhanced Endoscopy Filters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysplasia Detection Rate
Overall Dysplasia Detection rate
Measured: 2 years
Secondary outcomes (2)
Withdrawal times
Withdrawal time for procedure
Measured: 2 years
Characterisation of lesions
Accurate characterisation compared to histology
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start3 Apr 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Perth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherman Picardo, Royal Perth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266104
- Sponsor's protocol ID
- Protocol V1.4_04012024
- Status last verified
- Apr 2024
- First submitted
- 4 Feb 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image Enhanced Endoscopy Technology to Improve the Detection of Colorectal Dysplasia in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT06266104
- Acronym / sponsor ID
- Protocol V1.4_04012024
- Conditions
- Inflammatory Bowel Diseases, Dysplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Royal Perth HospitalUniversity, hospital or other
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 20 Feb 2024 (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.
Dye- spray chromoendoscopy remains the recommended gold standard approach for IBD dysplasia surveillance colonoscopy however recently published European and American guidelines recommend either dye-spray or virtual chromoendoscopy can be used for surveillance. The newer Imaged Enhanced Endoscopy technologies TXI and LCI have not formally been evaluated in IBD surveillance in a randomised controlled trial setting. These modes can easily be applied during colonoscopy and if demonstrated to be effective may save time and eliminate the need for dye-spray chromoendoscopy in the future.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dye Spray Chromoendoscopy | Placebo comparator | Procedure: Image Enhanced Endoscopy FiltersPatients undergoing surveillance with dye spray chromoendoscopy |
| TXI | Active comparator | Procedure: Image Enhanced Endoscopy FiltersPatients undergoing surveillance with TXI (Texture and Colour Enhancement Imaging) |
| LCI | Active comparator | Procedure: Image Enhanced Endoscopy FiltersPatients undergoing surveillance with LCI (Linked Colour Imaging ) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with inflammatory bowel disease aged 18 to 75 years, that meet Australian recommendations to undergo surveillance colonoscopy will be identified and invited participate in the study.
Key exclusion criteria (4 listed)
- Any active disease
- Inadequate bowel preparation
- Previous surgical resection involving the colon
- History of bowel cancer
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 |
|---|---|---|
| Image Enhanced Endoscopy FiltersPatients that undergoing surveillance and consent to be involved in the study will be randomised to undergo surveillance with LCI, TXI or dye-spray chromoendoscopy (methylene blue). | Procedure or surgery | Dye Spray Chromoendoscopy, LCI, TXI |
Primary outcome
Dysplasia Detection Rate
Time frame: 2 years
Overall Dysplasia Detection rate
2 secondary outcomes
Withdrawal times
Time frame: 2 years
Characterisation of lesions
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Image Enhanced Endoscopy Filters in people with Inflammatory Bowel Diseases and Dysplasia, run by Royal Perth Hospital at 1 site in Australia.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 Apr 2024. 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 Australia. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherman Picardo, MBBS (hon), MSc (0892242244, sherman.picardo@health.wa.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysplasia Detection Rate (time frame: 2 years). 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 12 Apr 2024.