Colorectal NeoplasmsINSIGHTNCT07797361
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
A study testing White Light Endoscopy, Versatile Intelligent Staining Technology and Spectral Flexible Imaging in people with Colorectal Neoplasms and Colonic Polyps, run by Alexandre Vontobel Padoin at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Colonic Polyps, Adenoma
- What is being tested?
- White Light Endoscopy, Versatile Intelligent Staining Technology and Spectral Flexible Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 990 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2026to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90160-090
Ari Ben Hur Stefani Leão, MD, +55 51 3195 2843, gpeg.pucrs@gmail.com
About this study
Official 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)
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.
Read the detailed description
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.
- Conditions
- Colorectal Neoplasms, Colonic Polyps, Adenoma, Serrated Polyps, Colorectal Cancer Screening
- Being tested
- White Light Endoscopy, Versatile Intelligent Staining Technology, Spectral Flexible Imaging
- Keywords
- Colonoscopy, Adenoma Detection Rate, Optical Diagnosis, Image-Enhanced Endoscopy, Electronic Chromoendoscopy, Versatile Intelligent Staining Technology (VIST), Spectral Flexible Imaging (SFI), White Light Endoscopy, JNET Classification, Kudo Pit Pattern
- Medical subject headings
- Colorectal Neoplasms, Colonic Polyps, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White Light EndoscopyDevice
Also called WLE
Colonoscopy performed using high-definition white light imaging.
Versatile Intelligent Staining TechnologyDevice
Also called VIST
Colonoscopy performed using Versatile Intelligent Staining Technology (VIST).
Spectral Flexible ImagingDevice
Also called SFI
Colonoscopy performed using Spectral Flexible Imaging (SFI).
| Study group | Role | What they receive |
|---|---|---|
| White Light Endoscopy (WLE) | Active comparator | 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. Receives: Device: White Light Endoscopy |
| Versatile Intelligent Staining Technology (VIST) | Experimental | 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. Receives: Device: Versatile Intelligent Staining Technology |
| Spectral Flexible Imaging (SFI) | Experimental | 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. Receives: Device: Spectral Flexible Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma Detection Rate (ADR)
Proportion of participants with ≥1 colorectal polyp detected during the first-look withdrawal phase using the allocated imaging modality.
Measured: During index colonoscopy.
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months after index colonoscopy (video-based assessment).
Procedure Quality Metrics
Withdrawal time (minutes), total procedure time (minutes), and cecal intubation rate.
Measured: During index colonoscopy.
Safety (Procedure-related Adverse Events)
Incidence of colonoscopy-related adverse events (e.g., bleeding, perforation, post-polypectomy complications).
Measured: Up to 24 hours after colonoscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1:1 ratio to one of three parallel groups: high-definition white light endoscopy (WLE), Versatile Intelligent Staining Technology (VIST), or Spectral Flexible Imaging (SFI). Each participant will undergo the first-look withdrawal phase using the imaging modality assigned to their study group
- Masking
- None (open label)
- Enrolment
- 990 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandre Vontobel Padoin
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Sao Lucas da PUCRS
- Responsible party
- Sponsor-investigator, Alexandre Vontobel Padoin, Pontificia Universidade Católica do Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797361
- Sponsor's protocol ID
- 00410826.8.0000.5336
- Acronym
- INSIGHT
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07797361
- Acronym / sponsor ID
- INSIGHT / 00410826.8.0000.5336
- Conditions
- Colorectal Neoplasms, Colonic Polyps, Adenoma, Serrated Polyps, Colorectal Cancer Screening
- Keywords
- Colonoscopy, Adenoma Detection Rate, Optical Diagnosis, Image-Enhanced Endoscopy, Electronic Chromoendoscopy, Versatile Intelligent Staining Technology (VIST), Spectral Flexible Imaging (SFI), White Light Endoscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 990 participants (estimated)
- Lead sponsor
- Alexandre Vontobel PadoinUniversity, hospital or other
- Collaborators
- Hospital Sao Lucas da PUCRS
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomized in a 1:1:1 ratio to one of three parallel groups: high-definition white light endoscopy (WLE), Versatile Intelligent Staining Technology (VIST), or Spectral Flexible Imaging (SFI). Each participant will undergo the first-look withdrawal phase using the imaging modality assigned to their study group
| Arm | Type | Receives |
|---|---|---|
| White Light Endoscopy (WLE) | Active comparator | Device: White Light EndoscopyParticipants 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) | Experimental | Device: Versatile Intelligent Staining TechnologyParticipants 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) | Experimental | Device: Spectral Flexible ImagingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| White Light EndoscopyAlso: WLEColonoscopy performed using high-definition white light imaging. | Device | White Light Endoscopy (WLE) |
| Versatile Intelligent Staining TechnologyAlso: VISTColonoscopy performed using Versatile Intelligent Staining Technology (VIST). | Device | Versatile Intelligent Staining Technology (VIST) |
| Spectral Flexible ImagingAlso: SFIColonoscopy performed using Spectral Flexible Imaging (SFI). | Device | Spectral Flexible Imaging (SFI) |
Primary outcome
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.
7 secondary outcomes
Serrated Lesion Detection Rate
Time frame: During index colonoscopy.
Diagnostic Accuracy for Optical Characterization (Neoplastic vs Non-neoplastic)
Time frame: During index colonoscopy with post-procedure histopathology results.
Agreement Between Optical Diagnosis and Histopathology
Time frame: During index colonoscopy with post-procedure histopathology results.
Concordance of Endoscopic Classifications With Histopathology
Time frame: During index colonoscopy with post-procedure histopathology results.
Interobserver and Intraobserver Agreement From Blinded Video Review
Time frame: Up to 12 months after index colonoscopy (video-based assessment).
Procedure Quality Metrics
Time frame: During index colonoscopy.
Safety (Procedure-related Adverse Events)
Time frame: Up to 24 hours after colonoscopy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White Light Endoscopy, Versatile Intelligent Staining Technology and Spectral Flexible Imaging in people with Colorectal Neoplasms and Colonic Polyps, run by Alexandre Vontobel Padoin at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ari Ben Hur Stefani Leão, MD (+55 51 3195 2843, gpeg.pucrs@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma Detection Rate (ADR) (time frame: During index colonoscopy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.