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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03515343
Recruitment Status : Completed
First Posted : May 3, 2018
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
Pentax Medical
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Tracking Information
First Submitted Date March 15, 2018
First Posted Date May 3, 2018
Last Update Posted Date July 8, 2019
Actual Study Start Date March 9, 2018
Actual Primary Completion Date March 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 2, 2018)
  • Concordance of Optical diagnosis with the pathology based reference standard [ Time Frame: 12 months ]
    The Optical diagnosis of polyps using Optivista or iScan will be compared with the pathology based reference standard.
  • Comparison of both of the technologies (Optivista and iScan) for Optical diagnosis [ Time Frame: 12 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03515343 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 2, 2018)
  • Negative predictive value of rectosigmoid neoplastic polyps. [ Time Frame: 12 months ]
    Secondary outcomes and data collection include test characteristics, particularly the negative predictive value of rectosigmoid neoplastic polyps.
  • Concordance of biopsies with WASP classification [ Time Frame: 12 months ]
    Verification of concordance (yes/no) between histopathological results (biopsies) and WASP classification for polyps up to 10mm in size in conjunction with iScan and Optivista (depending on randomization).
  • Concordance of biopsies and SIMPLE classification [ Time Frame: 12 months ]
    Verification of concordance (yes/no) between histopathological results (biopsies) and SIMPLE classification for polyps up to 10mm in size in conjunction with iScan and Optivista (depending on randomization).
  • Concordance of biopsies and SANO classification [ Time Frame: 12 months ]
    Verification of concordance (yes/no) between histopathological results (biopsies) and SANO classification for polyps up to 10mm in size in conjunction with iScan and Optivista (depending on randomization).
  • Concordance of biopsies and NICE classification [ Time Frame: 12 months ]
    Verification of concordance (yes/no) between histopathological results (biopsies) and NICE classification for polyps up to 10mm in size in conjunction with iScan and Optivista (depending on randomization).
  • Surveillance recommendation following the colonoscopy [ Time Frame: 12 months ]
    The proportion of patients for whom an immediate surveillance recommendation following the colonoscopy can be directly provided for each approach and how often histopathology polyp examination would have been avoided when using each strategy will be examined.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Optivista : I-SCAN OE for Optical Diagnosis of Small Colon Polyps
Official Title Optivista : I-SCAN OE for Optical Diagnosis of Small Colon Polyps
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.
Detailed Description

The benefit of colonoscopy screening is based on the detection and removal of polyps neoplastic. However, the vast majority of found polyps do not harbor any risk of non-cancer neoplastic. The resection evaluation and histopathology of these polyps are associated with costs while the contribution to cancer prevention is limited. A new technique (Pentax Optivista) based on visual diagnosis of polyps has been introduced to reduce the costs associated with over-screening, and seems to be more efficient than the Pentax iScan technique.

This research project aims to evaluate the new Optivista system compared to the iScan for his optical biopsy performance and interval agreement monitoring with pathology.

This is a prospective clinical trial for which participants are recruited directly from the colonoscopy clinic. The Participants will be randomized to be diagnosed by either Optivista or Pentax iScan. Endoscope withdrawal will be done in iScan 1 mode for patients randomized to iSan and in Optivista OE2 mode for patients randomized to Optivista.

For 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.

Polyps that are between 1-10mm in size (diminutive and small polyps), there will be further assessed according to WASP, NICE, SANO and SIMPLE classifications using white light imaging and using an image-enhancing endoscopy technology that enhances visualisation of the polyp surface and vascular patterns.

Concordance between optical diagnosis and pathology monitoring according to recommendations will be presented as proportions with a 95% CI. The features optical polyp diagnostic test for overall diminutive (1-5mm) polyps and by location in the colon (proximal, distal, colon and rectosigmoid segments) will be presented. For outcome measures secondary factors, including factors that may influence the optical diagnosis, proportional estimates with a 95% confidence interval (CI) will be presented. Concordance between strategies is examined using a marginal homogeneity test (Stuart-Maxwell test). For the comparison of proportions, a chi square test or a Fisher's exact two-sided test will be used, as appropriate.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
Biopsy of colorectal polyps detected during the observed colonoscopy.
Sampling Method Probability Sample
Study Population Participants will be recruited at the endoscopy unit at the CHUM, before undergoing an elective colonoscopy.
Condition
  • Colo-rectal Cancer
  • Polyps of Colon
Intervention 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).
Study Groups/Cohorts
  • Optical diagnosis with Optivista
    Participants for which the optical diagnosis of detected colorectal polyps will be done with the new technique Pentax Optivista.
    Intervention: 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.
    Intervention: Diagnostic Test: Screening colonoscopy according to resect-and-discard strategy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 2, 2018)
411
Original Estimated Enrollment Same as current
Actual Study Completion Date March 31, 2019
Actual Primary Completion Date March 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Known inflammatory bowel disease
  • Active colitis
  • Coagulopathy
  • Familial polyposis syndrome
  • Poor general health defined as an ASA class > 3
  • Emergency colonoscopies
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03515343
Other Study ID Numbers 17.135
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Centre hospitalier de l'Université de Montréal (CHUM)
Study Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators Pentax Medical
Investigators
Principal Investigator: Daniel von Renteln, MD, PhD Centre Hospitalier Universitaire de Montréal, Research Center (CRCHUM)
PRS Account Centre hospitalier de l'Université de Montréal (CHUM)
Verification Date March 2018