An interventional study of White Light Endoscopy and Versatile Intelligent Staining Technology in Colorectal Neoplasms, Colonic Polyps and Adenoma, sponsored by Alexandre Vontobel Padoin. Not yet recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Alexandre Vontobel Padoin · Not applicable, Interventional, and Diagnostic
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.
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.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 990 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →This is the only study on the registry with Alexandre Vontobel Padoin as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: White Light Endoscopy
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.
Device: Versatile Intelligent Staining Technology
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.
Device: Spectral Flexible Imaging
Colonoscopy performed using high-definition white light imaging.
Also known as: WLE
Colonoscopy performed using Versatile Intelligent Staining Technology (VIST).
Also known as: VIST
Colonoscopy performed using Spectral Flexible Imaging (SFI).
Also known as: SFI
Adenoma Detection Rate (ADR)
Proportion of participants with ≥1 colorectal polyp detected during the first-look withdrawal phase using the allocated imaging modality.
Time frame: During index colonoscopy.
Serrated Lesion Detection Rate
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.
Time frame: During index colonoscopy.
Diagnostic Accuracy for Optical Characterization (Neoplastic vs Non-neoplastic)
Sensitivity, specificity, PPV, NPV, and overall accuracy of optical diagnosis for neoplastic versus non-neoplastic colorectal lesions, using histopathology as the reference standard.
Time frame: During index colonoscopy with post-procedure histopathology results.
Agreement Between Optical Diagnosis and Histopathology
Agreement (Cohen's kappa) between in vivo optical diagnosis and histopathology for colorectal lesions.
Time frame: During index colonoscopy with post-procedure histopathology results.
Concordance of Endoscopic Classifications With Histopathology
Agreement (Cohen's kappa) between endoscopic classifications (Paris, Kudo pit pattern, and JNET) assigned in vivo and histopathology.
Time frame: During index colonoscopy with post-procedure histopathology results.
Interobserver and Intraobserver Agreement From Blinded Video Review
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.
Time frame: Up to 12 months after index colonoscopy (video-based assessment).
Procedure Quality Metrics
Withdrawal time (minutes), total procedure time (minutes), and cecal intubation rate.
Time frame: During index colonoscopy.
Safety (Procedure-related Adverse Events)
Incidence of colonoscopy-related adverse events (e.g., bleeding, perforation, post-polypectomy complications).
Time frame: Up to 24 hours after colonoscopy.
Plan to share: Undecided — The individual participant data (IPD) sharing plan has not yet been determined. Any future sharing of de-identified participant data will be subject to applicable ethical and institutional requirements, participant confidentiality protections, and relevant data protection regulations.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jan 2027, 3 months later.
Of 898 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 62. This study's planned 3 months is below that.
Counting every sponsor, half of 955 studies reached it within 32 months; a quarter within 14 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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