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
INSIGHT
1 other identifier
interventional
990
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2026
CompletedFirst Posted
Study publicly available on registry
September 1, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2028
September 1, 2026
August 1, 2026
4 months
August 26, 2026
August 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adenoma Detection Rate (ADR)
Proportion of participants with ≥1 colorectal polyp detected during the first-look withdrawal phase using the allocated imaging modality.
During index colonoscopy.
Secondary Outcomes (7)
Serrated Lesion Detection Rate
During index colonoscopy.
Diagnostic Accuracy for Optical Characterization (Neoplastic vs Non-neoplastic)
During index colonoscopy with post-procedure histopathology results.
Agreement Between Optical Diagnosis and Histopathology
During index colonoscopy with post-procedure histopathology results.
Concordance of Endoscopic Classifications With Histopathology
During index colonoscopy with post-procedure histopathology results.
Interobserver and Intraobserver Agreement From Blinded Video Review
Up to 12 months after index colonoscopy (video-based assessment).
- +2 more secondary outcomes
Study Arms (3)
White Light Endoscopy (WLE)
ACTIVE COMPARATORParticipants 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.
Versatile Intelligent Staining Technology (VIST)
EXPERIMENTALParticipants 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.
Spectral Flexible Imaging (SFI)
EXPERIMENTALParticipants 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.
Interventions
Colonoscopy performed using high-definition white light imaging.
Colonoscopy performed using Versatile Intelligent Staining Technology (VIST).
Colonoscopy performed using Spectral Flexible Imaging (SFI).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alexandre Vontobel Padoinlead
- Hospital Sao Lucas da PUCRScollaborator
Study Sites (1)
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90160-090, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 26, 2026
First Posted
September 1, 2026
Study Start
October 1, 2026
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
August 31, 2028
Last Updated
September 1, 2026
Record last verified: 2026-08