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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

Name: 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 — clinical trial record (NCT07797361)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: INSIGHT

StatusNot Yet Recruiting

PhaseNot applicable

SponsorAlexandre Vontobel Padoin

Started2026-10-01

View on ClinicalTrials.gov ↗

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.

Trial Details

NCT Number	NCT07797361
Lead Sponsor	Alexandre Vontobel Padoin Collaborators: Hospital Sao Lucas da PUCRS
Conditions	Colorectal Neoplasms, Colonic Polyps, Adenoma, Serrated Polyps, Colorectal Cancer Screening
Enrollment	990 participants
Start Date	2026-10-01
Primary Completion	2027-01-31 (estimated)
Study Completion	2028-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-09-01