Image Enhanced Endoscopy IBD

April 10, 2024 updated by: Sherman Picardo, Royal Perth Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Recruiting
        • Royal Perth Hosptial
        • Contact:
          • Sherman Picardo, MBBS
          • Phone Number: 92242244

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Dye Spray Chromoendoscopy
Patients undergoing surveillance with dye spray chromoendoscopy
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).
Active Comparator: TXI
Patients undergoing surveillance with TXI (Texture and Colour Enhancement Imaging)
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).
Active Comparator: LCI
Patients undergoing surveillance with LCI (Linked Colour Imaging )
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dysplasia Detection Rate
Time Frame: 2 years
Overall Dysplasia Detection rate
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Withdrawal times
Time Frame: 2 years
Withdrawal time for procedure
2 years
Characterisation of lesions
Time Frame: 2 years
Accurate characterisation compared to histology
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Perth Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

February 4, 2024

First Submitted That Met QC Criteria

February 10, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol V1.4_04012024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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