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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

NCT07797361 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 990

Last updated 2026-09-01

No results posted yet for this study

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.

Conditions

  • Colorectal Neoplasms
  • Colonic Polyps
  • Adenoma
  • Serrated Polyps
  • Colorectal Cancer Screening

Interventions

DEVICE

White Light Endoscopy

Colonoscopy performed using high-definition white light imaging.

DEVICE

Versatile Intelligent Staining Technology

Colonoscopy performed using Versatile Intelligent Staining Technology (VIST).

DEVICE

Spectral Flexible Imaging

Colonoscopy performed using Spectral Flexible Imaging (SFI).

Sponsors & Collaborators

  • Hospital Sao Lucas da PUCRS

    collaborator OTHER

  • Alexandre Vontobel Padoin

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2027-01-31
Completion
2028-08-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07797361 on ClinicalTrials.gov