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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06266104




Registration number
NCT06266104
Ethics application status
Date submitted
4/02/2024
Date registered
20/02/2024
Date last updated
12/04/2024

Titles & IDs
Public title
Image Enhanced Endoscopy IBD
Scientific title
Image Enhanced Endoscopy Technology to Improve the Detection of Colorectal Dysplasia in Patients With Inflammatory Bowel Disease
Secondary ID [1] 0 0
Protocol V1.4_04012024
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Diseases 0 0
Dysplasia 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Image Enhanced Endoscopy Filters

Placebo comparator: Dye Spray Chromoendoscopy - Patients undergoing surveillance with dye spray chromoendoscopy

Active comparator: TXI - Patients undergoing surveillance with TXI (Texture and Colour Enhancement Imaging)

Active comparator: LCI - Patients undergoing surveillance with LCI (Linked Colour Imaging )


Treatment: Surgery: Image Enhanced Endoscopy Filters
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).
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dysplasia Detection Rate
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
Withdrawal times
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Characterisation of lesions
Timepoint [2] 0 0
2 years

Eligibility
Key inclusion criteria
* 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Any active disease
* Inadequate bowel preparation
* Previous surgical resection involving the colon
* History of bowel cancer

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2026
Actual
Sample size
Target
270
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Royal Perth Hosptial - Perth
Recruitment postcode(s) [1] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Royal Perth Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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. 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.
Trial website
https://clinicaltrials.gov/study/NCT06266104
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sherman Picardo, MBBS (hon), MSc
Address 0 0
Country 0 0
Phone 0 0
0892242244
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06266104