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NCT Number: 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

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.

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Key information

Conditions

Colorectal Neoplasms Adenoma Colonic Diseases Colonic Polyps Colorectal Cancer Screening Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Rectal Diseases Serrated Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, 90160-090, Brazil

Location contact

Ari Ben Hur Stefani Leão, MD

CONTACT

[email protected]

+55 51 3195 2843

About this study

This prospective randomized controlled study will compare high-definition white light endoscopy (WLE), Versatile Intelligent Staining Technology (VIST), and Spectral Flexible Imaging (SFI) for the detection and optical characterization of colorectal lesions during colonoscopy.

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 allocated modality. Detected lesions will be documented and characterized in vivo according to their location, size, morphology, and established endoscopic classification systems, including the Paris, Kudo, and JNET classifications. Lesions will subsequently be biopsied or resected as clinically appropriate and submitted for histopathological evaluation, which will serve as the reference standard for diagnostic performance analyses.

Standardized recordings of colorectal lesions will also be used for blinded review to assess interobserver and intraobserver agreement in optical diagnosis and endoscopic classification. In addition to evaluating lesion detection and characterization, the study will compare procedural quality metrics and safety across the imaging modalities.

The study is designed to determine whether VIST or SFI can improve colorectal lesion detection and optical characterization compared with conventional high-definition white light endoscopy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

White light Endoscopy

Device

Colonoscopy performed using high-definition white light imaging.

Other names: WLE

Versatile Intelligent Staining Technology

Device

Colonoscopy performed using Versatile Intelligent Staining Technology (VIST).

Other names: VIST

Spectral Flexible Imaging

Device

Colonoscopy performed using Spectral Flexible Imaging (SFI).

Other names: SFI

Primary outcomes

  1. Adenoma Detection Rate (ADR)

    Time frame: During index colonoscopy.

    Proportion of participants with ≥1 colorectal polyp detected during the first-look withdrawal phase using the allocated imaging modality.

Secondary outcomes

  1. Serrated Lesion Detection Rate

    Time frame: During index colonoscopy.

    Proportion of participants with ≥1 serrated lesion (e.g., sessile serrated lesion or hyperplastic polyp) detected during the first-look withdrawal phase using the allocated imaging modality, with histopathology confirmation when available.

  2. Diagnostic Accuracy for Optical Characterization (Neoplastic vs Non-neoplastic)

    Time frame: During index colonoscopy with post-procedure histopathology results.

    Sensitivity, specificity, PPV, NPV, and overall accuracy of optical diagnosis for neoplastic versus non-neoplastic colorectal lesions, using histopathology as the reference standard.

  3. Agreement Between Optical Diagnosis and Histopathology

    Time frame: During index colonoscopy with post-procedure histopathology results.

    Agreement (Cohen's kappa) between in vivo optical diagnosis and histopathology for colorectal lesions.

  4. Concordance of Endoscopic Classifications With Histopathology

    Time frame: During index colonoscopy with post-procedure histopathology results.

    Agreement (Cohen's kappa) between endoscopic classifications (Paris, Kudo pit pattern, and JNET) assigned in vivo and histopathology.

  5. Interobserver and Intraobserver Agreement From Blinded Video Review

    Time frame: Up to 12 months after index colonoscopy (video-based assessment).

    Interobserver and intraobserver agreement (Cohen's kappa) for optical diagnosis and classification based on standardized video recordings of lesions reviewed independently and blinded to group allocation and histopathology.

  6. Procedure Quality Metrics

    Time frame: During index colonoscopy.

    Withdrawal time (minutes), total procedure time (minutes), and cecal intubation rate.

  7. Safety (Procedure-related Adverse Events)

    Time frame: Up to 24 hours after colonoscopy.

    Incidence of colonoscopy-related adverse events (e.g., bleeding, perforation, post-polypectomy complications).

Study contacts

Contact information is provided by the study sponsor or research team.

Ari Ben Hur Stefani Leão, MD

CONTACT

[email protected]

+55 51 3195 2843

Sponsors and collaborators

Lead sponsor

Alexandre Vontobel Padoin

Other

Collaborators

  • Hospital Sao Lucas da PUCRS

Registry information

Official study title

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 Study)

Acronym: INSIGHT

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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