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Evaluation of Versatile Intelligent Staining Technology (VIST) and Spectral Flexible Imaging (SFI) for Detection and Optical Characterization of Colorectal Lesions: A Prospective Randomized Controlled Study
Sponsor: Alexandre Vontobel Padoin
Summary
This prospective randomized controlled study aims to evaluate the diagnostic accuracy of Versatile Intelligent Staining Technology (VIST) and Spectral Flexible Imaging (SFI) for detection and optical characterization of colorectal lesions during colonoscopy. The performance of VIST and SFI will be compared with high-definition white light endoscopy (WLE), using histopathology as the reference standard and established endoscopic classifications (Paris, Kudo, and JNET). The study will also assess adenoma detection rate, serrated lesion detection, inter- and intraobserver agreement, and procedure-related metrics.
Official title: Evaluation of Versatile Intelligent Staining Technology (VIST) and Spectral Flexible Imaging (SFI) for Detection and Optical Characterization of Colorectal Lesions: A Prospective Randomized Controlled Study (INSIGHT Study)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
990
Start Date
2026-10-01
Completion Date
2028-08-31
Last Updated
2026-09-01
Healthy Volunteers
No
Interventions
White Light Endoscopy
Colonoscopy performed using high-definition white light imaging.
Versatile Intelligent Staining Technology
Colonoscopy performed using Versatile Intelligent Staining Technology (VIST).
Spectral Flexible Imaging
Colonoscopy performed using Spectral Flexible Imaging (SFI).
Locations (1)
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil