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Artificial Intelligence in the Characterization of Colorectal Polyps

NCT04749277 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 197

Last updated 2021-07-28

No results posted yet for this study

Summary

Current guidelines recommend resection and histopathological analyses of all colorectal polyps. Real-time optical diagnosis can obviate non-neoplastic polyp resection ("diagnose-and-leave-behind") and histopathological analyses of diminutive polyps ("predict-resect-and-discard") reducing healthcare and cost burden. The investigators aimed to evaluate the diagnostic accuracy of computer-aided diagnosis using CAD EYE® (Fujifilm,Germany) in real-time optical characterization of colorectal polyps compared to endoscopic diagnosis with histopathology as the gold-standard. For this purpose, a single-centre prospective study of diminutive/small colorectal polyps is ongoing.

Conditions

  • Colonic Polyps

Interventions

OTHER

CAD EYE® (Fujifilm, Europe, Gesellschaft mit beschränkter Haftung, Dusseldorf, Germany)

Methods plan Phase 1. Brief virtual chromoendoscopy training on the characterization of colorectal polyps (WLI, LCI and BLI) Phase 2. CAD EYE® system applied during colonoscopy retrieval: 2.1. CAD EYE® system OFF: Virtual chromoendoscopy (BLI) - independently characterization of a suspected polyp in WLI and BLI by the first endoscopist and by the second endoscopist (iconographic record) 2.2. CAD EYE® system ON: Characterization mode (BLI): Characterization of a suspected polyp by CAD EYE® and respectively level of characterization (1 to 3) (iconographic record) Phase 3. Histopathological evaluation (pathologist with gastrointestinal expertise): Resection and recovery of a suspected polyp for anatomopathological characterization

Sponsors & Collaborators

  • Unidade Local de Saúde de Coimbra, EPE

    lead OTHER

Principal Investigators

  • Elisa Gravito-Soares, MD · Unidade Local de Saúde de Coimbra, EPE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2021-02-28
Completion
2021-04-30

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04749277 on ClinicalTrials.gov