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Optivista : I-SCAN OE for Optical Diagnosis of Small Colon Polyps

NCT03515343 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 411

Last updated 2021-07-19

No results posted yet for this study

Summary

This prospective randomized clinical trial aims to evaluate the new Optivista system compared to the iScan for his optical diagnosis and interval agreement monitoring with pathology. The Participants will be randomized to be diagnosed by either Optivista or Pentax iScan, and all polyps detected during the procedure, their size, location and morphology will be recorded according to the Paris classification after which all polyps will be resected per standard practices and sent for histopathologic evaluation. Further optical assessments will be performed for all polyps of 1-10 mm in size (WASP, NICE, SANO and SIMPLE classification) after with an analysis of comparison between optical diagnosis and pathology results will be performed.

Conditions

  • Colo-rectal Cancer
  • Polyps of Colon

Interventions

DIAGNOSTIC_TEST

Screening colonoscopy according to resect-and-discard strategy

This strategy uses image enhancing techniques and optical diagnosis instead of histopathology assessment with 2 Pentax optical imaging systems (either Optivista or iScan).

Sponsors & Collaborators

  • Pentax Medical

    collaborator INDUSTRY

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • Daniel von Renteln, MD, PhD · Centre Hospitalier Universitaire de Montréal, Research Center (CRCHUM)

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-09
Primary Completion
2019-03-31
Completion
2019-03-31

Countries

  • Canada

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 NCT03515343 on ClinicalTrials.gov