Collecting Recorded Videos of Colonoscopy

• ClinicalTrials.gov Identifier: NCT03891251
• Recruitment Status: Recruiting
• First Posted: March 27, 2019
• Last Update Posted: November 16, 2020
• Sponsor: Magentiq Eye LTD
• 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.

• 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

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

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