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

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
This prospective randomized controlled study will compare high‐definition white lightendoscopy (WLE), Versatile Intelligent Staining Technology (VIST), and Spectral FlexibleImaging (SFI) for the detection and optical characterization of colorectal lesions duringcolonoscopy.Participants will be randomized in a 1:1:1 ratio to one of the three imaging modalities.During the first‐look withdrawal phase, the colon will be examined using the allocatedmodality. Detected lesions will be documented and characterized in vivo according totheir location, size, morphology, and established endoscopic classification systems,including the Paris, Kudo, and JNET classifications. Lesions will subsequently bebiopsied or resected as clinically appropriate and submitted for histopathologicalevaluation, which will serve as the reference standard for diagnostic performanceanalyses.Standardized recordings of colorectal lesions will also be used for blinded review toassess interobserver and intraobserver agreement in optical diagnosis and endoscopicclassification. In addition to evaluating lesion detection and characterization, thestudy will compare procedural quality metrics and safety across the imaging modalities.The study is designed to determine whether VIST or SFI can improve colorectal lesiondetection and optical characterization compared with conventional high‐definition whitelight endoscopy.
Epistemonikos ID: 0e68bc687abe0811b815c429aae404e5f84869bf
First added on: Sep 01, 2026