NCT03515343

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
411

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 3, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

July 19, 2021

Status Verified

March 1, 2018

Enrollment Period

1.1 years

First QC Date

March 15, 2018

Last Update Submit

July 14, 2021

Conditions

Colo-rectal CancerPolyps of Colon

Keywords

Cancer preventionEndoscopyGastroenterology

Outcome Measures

Primary Outcomes (2)

  • Concordance of Optical diagnosis with the pathology based reference standard

    The Optical diagnosis of polyps using Optivista or iScan will be compared with the pathology based reference standard.

    12 months

  • Rate of polyps detected of both of the technologies (Optivista and iScan) for Optical diagnosis

    12 months

Secondary Outcomes (7)

  • Negative predictive value of rectosigmoid neoplastic polyps.

    12 months

  • Concordance of biopsies with WASP classification

    12 months

  • Concordance of biopsies and SIMPLE classification

    12 months

  • Concordance of biopsies and SANO classification

    12 months

  • Concordance of biopsies and NICE classification

    12 months

  • +2 more secondary outcomes

Study Arms (2)

Optical diagnosis with Optivista

Participants for which the optical diagnosis of detected colorectal polyps will be done with the new technique Pentax Optivista.

Diagnostic Test: Screening colonoscopy according to resect-and-discard strategy

Optical diagnosis with iScan

Participants for which the optical diagnosis of detected colorectal polyps will be done with the oldest technique Pentax iScan.

Diagnostic Test: Screening colonoscopy according to resect-and-discard strategy

Interventions

Screening colonoscopy according to resect-and-discard strategyDIAGNOSTIC_TEST

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

Optical diagnosis with OptivistaOptical diagnosis with iScan

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants will be recruited at the endoscopy unit at the CHUM, before undergoing an elective colonoscopy.

You may qualify if:

  • Signed informed consent
  • Aged 45 to 80 years
  • Indication for full colonoscopy

You may not qualify if:

  • Known inflammatory bowel disease
  • Active colitis
  • Coagulopathy
  • Familial polyposis syndrome
  • Poor general health defined as an ASA class \> 3
  • Emergency colonoscopies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Montréal (CHUM)

Montreal, Quebec, Canada

Location

Related Publications (1)

  • Djinbachian R, Marchand E, Pohl H, Aguilera-Fish A, Bouin M, Deslandres E, Weber A, Bouchard S, Panzini B, von Renteln D. Optical diagnosis of colorectal polyps: a randomized controlled trial comparing endoscopic image-enhancing modalities. Gastrointest Endosc. 2021 Mar;93(3):712-719.e1. doi: 10.1016/j.gie.2020.11.023. Epub 2020 Dec 2.

    PMID: 33275913DERIVED

Biospecimen

Retention: NONE RETAINED

Biopsy of colorectal polyps detected during the observed colonoscopy.

MeSH Terms

Conditions

Colonic NeoplasmsColonic Polyps

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesIntestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel von Renteln, MD, PhD

    Centre Hospitalier Universitaire de Montréal, Research Center (CRCHUM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2018

First Posted

May 3, 2018

Study Start

March 9, 2018

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

July 19, 2021

Record last verified: 2018-03

Locations

CA(1)