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NCT07797361Not yet recruiting

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

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)

Source: ClinicalTrials.gov · Last updated 1 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
990 (estimated)
First submitted
26 Aug 2026
Start date
Oct 2026
Primary completion date
Jan 2027
Lead sponsor
Alexandre Vontobel Padoin
NCT number
NCT07797361

What you commit to

  • Study type: Interventional
  • Planned participants: 990
  • From Oct 2026 to the primary completion date, Jan 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior colorectal resection

Other illness

  • History of inflammatory bowel disease (Crohn's disease or ulcerative colitis)

Other

  • Colorectal stenosis preventing scope progression
  • Pregnancy or breastfeeding
  • Inadequate bowel preparation
  • Clinical contraindication to colonoscopy

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Sao Lucas da PUCRS
Coordinator of this site? Confirm its status
Porto AlegreBrazilUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.