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
Study ID
NCT07797361
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • White Light Endoscopy — DEVICE
    Colonoscopy performed using high-definition white light imaging.
  • Versatile Intelligent Staining Technology — DEVICE
    Colonoscopy performed using Versatile Intelligent Staining Technology (VIST).
  • Spectral Flexible Imaging — DEVICE
    Colonoscopy performed using Spectral Flexible Imaging (SFI).

Study Details

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.

Key Dates

First listed
Sep 1, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Jan 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
990 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: White Light Endoscopy (WLE)
    Participants randomized to this arm will undergo colonoscopy using high-definition white light endoscopy (WLE) during the first-look withdrawal phase. Colorectal lesions detected during this phase will be documented and optically characterized according to the study protocol. Detected lesions will be biopsied or resected as clinically appropriate and submitted for histopathological evaluation.
  • Experimental: Versatile Intelligent Staining Technology (VIST)
    Participants randomized to this arm will undergo colonoscopy using Versatile Intelligent Staining Technology (VIST) during the first-look withdrawal phase. Colorectal lesions detected during this phase will be documented and optically characterized according to the study protocol. Detected lesions will be biopsied or resected as clinically appropriate and submitted for histopathological evaluation.
  • Experimental: Spectral Flexible Imaging (SFI)
    Participants randomized to this arm will undergo colonoscopy using Spectral Flexible Imaging (SFI) during the first-look withdrawal phase. Colorectal lesions detected during this phase will be documented and optically characterized according to the study protocol. Detected lesions will be biopsied or resected as clinically appropriate and submitted for histopathological evaluation.

Primary Outcome Measure

Adenoma Detection Rate (ADR) [ Time Frame: During index colonoscopy. ]

Central Contacts

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