Image Enhanced Endoscopy IBD
Image Enhanced Endoscopy Technology to Improve the Detection of Colorectal Dysplasia in Patients With Inflammatory Bowel Disease
1 other identifier
interventional
270
1 country
1
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2024
CompletedFirst Posted
Study publicly available on registry
February 20, 2024
CompletedStudy Start
First participant enrolled
April 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedApril 12, 2024
April 1, 2024
1.7 years
February 4, 2024
April 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Dysplasia Detection Rate
Overall Dysplasia Detection rate
2 years
Secondary Outcomes (2)
Withdrawal times
2 years
Characterisation of lesions
2 years
Study Arms (3)
Dye Spray Chromoendoscopy
PLACEBO COMPARATORPatients undergoing surveillance with dye spray chromoendoscopy
TXI
ACTIVE COMPARATORPatients undergoing surveillance with TXI (Texture and Colour Enhancement Imaging)
LCI
ACTIVE COMPARATORPatients undergoing surveillance with LCI (Linked Colour Imaging )
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Any active disease
- Inadequate bowel preparation
- Previous surgical resection involving the colon
- History of bowel cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Perth Hosptial
Perth, Western Australia, 6000, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor, Principal Investigator
Study Record Dates
First Submitted
February 4, 2024
First Posted
February 20, 2024
Study Start
April 3, 2024
Primary Completion
December 31, 2025
Study Completion
March 1, 2026
Last Updated
April 12, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share