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NCT06266104 Clinical Trial

Image Enhanced Endoscopy IBD

Inflammatory Bowel Diseases Clinical Trial

Official title:
Image Enhanced Endoscopy Technology to Improve the Detection of Colorectal Dysplasia in Patients With Inflammatory Bowel Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06266104
Other study ID # Protocol V1.4_04012024
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 3, 2024
Est. completion date March 1, 2026

Study information
Verified date April 2024
Source Royal Perth Hospital
Contact Sherman Picardo, MBBS (hon), MSc
Phone 0892242244
Email sherman.picardo@health.wa.gov.au
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 270
Est. completion date March 1, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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. Exclusion Criteria: - Any active disease - Inadequate bowel preparation - Previous surgical resection involving the colon - History of bowel cancer

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• 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).

Locations
Country Name City State
Australia Royal Perth Hosptial Perth Western Australia

Sponsors (1)
Lead Sponsor Collaborator
Royal Perth Hospital

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dysplasia Detection Rate Overall Dysplasia Detection rate 2 years
Secondary Withdrawal times Withdrawal time for procedure 2 years
Secondary Characterisation of lesions Accurate characterisation compared to histology 2 years
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