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Not Yet Recruiting NCT07797361

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

Conditions: Colorectal Neoplasms, Colonic Polyps, Adenoma, Serrated Polyps, Colorectal Cancer Screening

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 990
Sponsor: Alexandre Vontobel Padoin

Location: Hospital São Lucas da PUCRS Porto Alegre Rio Grande do Sul

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.

Eligibility Criteria

Inclusion Criteria: * Age ≥ 18 years * Undergoing screening or surveillance colonoscopy * Adequate bowel preparation (Boston Bowel Preparation Scale ≥6, with ≥2 per segment) * Ability to understand and sign informed consent Exclusion Criteria: * History of inflammatory bowel disease (Crohn's disease or ulcerative colitis) * Prior colorectal resection * Colorectal stenosis preventing scope progression * Pregnancy or breastfeeding * Inadequate bowel preparation * Clinical contraindication to colonoscopy

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07797361). StuddyBuddy aggregates publicly available trial information.