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Image Enhanced Endoscopy IBD

R

Royal Perth Hospital

Status

Enrolling

Conditions

Dysplasia
Inflammatory Bowel Diseases

Treatments

Procedure: Image Enhanced Endoscopy Filters

Study type

Interventional

Funder types

Other

Identifiers

NCT06266104
Protocol V1.4_04012024

Details and patient eligibility

About

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.

Enrollment

270 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

270 participants in 3 patient groups, including a placebo group

Dye Spray Chromoendoscopy
Placebo Comparator group
Description:
Patients undergoing surveillance with dye spray chromoendoscopy
Treatment:
Procedure: Image Enhanced Endoscopy Filters
TXI
Active Comparator group
Description:
Patients undergoing surveillance with TXI (Texture and Colour Enhancement Imaging)
Treatment:
Procedure: Image Enhanced Endoscopy Filters
LCI
Active Comparator group
Description:
Patients undergoing surveillance with LCI (Linked Colour Imaging )
Treatment:
Procedure: Image Enhanced Endoscopy Filters

Trial contacts and locations

1

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Central trial contact

Sherman Picardo, MBBS (hon), MSc

Data sourced from clinicaltrials.gov

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