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Collecting Recorded Videos of Colonoscopy

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ClinicalTrials.gov Identifier: NCT03891251
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : November 16, 2020
Sponsor:
Information provided by (Responsible Party):
Magentiq Eye LTD

Tracking Information
First Submitted Date March 9, 2019
First Posted Date March 27, 2019
Last Update Posted Date November 16, 2020
Actual Study Start Date December 19, 2018
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 3, 2019)
  • Recorded colonoscopy video which was verified by visual inspection to have sufficient high quality. [ Time Frame: Half an hour from the end of the procedure at which the video was recorded. ]
    Each recorded video is visually inspected immediately at the end of the procedure by an experienced team member who rates it with a number between 1 (the lowest quality) to 10 (the highest quality). This is a quality scale which indicates the general quality of the recorded video. Only videos with rate above 7 are considered as having sufficient high quality that enables to use them and analyze them.
  • De-Identified procedure report which was visually inspected to verify that it includes all the needed details about the polyps that were detected during the procedure. [ Time Frame: Half an hour from the end of the procedure for which the procedure report was filled-in. ]
    Each de-Identified procedure report is visually inspected immediately at the end of the procedure by an experienced team member who gives it binary score (0 or 1), 1 if it includes all the needed details about the polyps that were detected during the procedure, and 0 if does not include all the needed details about the polyps that were detected during the procedure. Only procedure reports which get the value of 1 can be used for full analysis of the recorded procedure.
Original Primary Outcome Measures
 (submitted: March 23, 2019)
  • Recorded colonoscopy video which was verified by visual inspection to have sufficient high quality. [ Time Frame: Half an hour from the end of the procedure at which the video was recorded. ]
    Each recorded video is visually inspected immediately at the end of the procedure by an experienced team member who rates it with a number between 1 (low quality) to 10 (high quality). Only videos with rate above 7 are considered as having sufficient high quality.
  • De-Identified procedure report which was visually inspected to verify that it includes all the needed details about the polyps that were detected during the procedure. [ Time Frame: Half an hour from the end of the procedure for which the procedure report was filled-in. ]
    Each de-Identified procedure report is visually inspected immediately at the end of the procedure by an experienced team member who gives it binary score (0 or 1), 1 if it includes all the needed details about the polyps that were detected during the procedure, and 0 if does not include all the needed details about the polyps that were detected during the procedure.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Collecting Recorded Videos of Colonoscopy
Official Title Collecting Recorded Videos of Colonoscopy Screening Tests for the Evaluation of the Automatic Polyp Detection System (APDS) Medical Device
Brief Summary The study shall mainly help to better evaluate the performance the APDS device and secondly it may help to assess the potential of the future alpha version of the device to be a useful and effective for the detection of colon Polyps.
Detailed Description

Primary objectives • To evaluate, in objective way, the usability of the future alpha version of the APDS device by testing the sensitivity and specificity of its results achieved from running it on the collected recorded videos of Colonoscopy screening tests of the general population.

Secondary objectives

• When the APDS would be ready for field installation (Beta Version), to install it in the Gastroenterology institute of the medical center, in order to evaluate, as part of a continuation study, the physicians satisfaction from the APDS performance.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

Subjects shall be recruited by the investigator from within the investigator's patient population of colonoscopy. In this study one site will participate and enroll not less than 250 patients and up to 700 subjects according to the inclusion/exclusion criteria. Each subject (not less than 250 patients and up to 700 subjects) included will pass one regular colonoscopy screening test which will be recorded in the way which is described above.

Enrolled subjects that did not complete the full course of the study will be replaced.

Condition Colon Polyp
Intervention Other: Collecting recorded videos of Colonoscopy screening tests
To evaluate, in objective way, the usability of the future alpha version of the APDS device by testing the sensitivity and specificity of its results achieved from running it on the collected recorded videos of Colonoscopy screening tests of the general population.
Study Groups/Cohorts Not Provided
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 Recruiting
Estimated Enrollment
 (submitted: November 13, 2020)
700
Original Estimated Enrollment
 (submitted: March 23, 2019)
300
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Subjects must meet all the - criteria related to regular colonoscopy according to the standard of care at the Gastroenterology Department of the selected center, _In addition the following - criteria have to be met to be eligible for the study:

  1. Able to read, understand and provide written Informed Consent;
  2. Females or males - older than 18 years old

Exclusion Criteria:

Any of the following colonoscopy related exclusion criteria will exclude the subject from the study:

  • Bleeding disorder or unacceptable risk of bleeding
  • Terminal illness or life threatening malignancy
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Dror Zur, Ph.D. +972(54)7555922 dror@magentiq.com
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT03891251
Other Study ID Numbers 0493-18-HMO
Has Data Monitoring Committee Not Provided
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 Magentiq Eye LTD
Study Sponsor Magentiq Eye LTD
Collaborators Not Provided
Investigators
Principal Investigator: Harold Jacob, MD Senior Gastroenterologist
PRS Account Magentiq Eye LTD
Verification Date March 2020