Collecting Recorded Videos of Colonoscopy Screening Tests

Collecting Recorded Videos of Colonoscopy Screening Tests for the Evaluation of the Automatic Polyp Detection System (APDS) Medical Device

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.

Study Overview

• Status: Completed
• Conditions: Colon Polyp
• Intervention / Treatment: Other: Collecting recorded videos of Colonoscopy screening tests of the general population

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
• Enrollment (Actual): 166

Contacts and Locations

Study Locations

• Israel
  • Hadera, Israel, 3810101
    • Hillel Yaffe Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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 up to 300 subjects according to the inclusion/exclusion criteria. Each subject (up to 300 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.

Description

Inclusion Criteria:

Subjects must meet all the criteria related to regular colonoscopy according to the standard of care at the Gastroenterolgy Department of the selected center. In addation, 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recorded colonoscopy video which was verified by visual inspection to have sufficient high quality.	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.	Half an hour from the end of the procedure at which the video was recorded.
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.	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 it does not include all the needed details about the polyps that were detected during the procedure.	Half an hour from the end of the procedure for which the procedure report was filled-in.

Collaborators and Investigators

• Sponsor: Magentiq Eye LTD
• Investigators: Principal Investigator: Yael Kopelman, MD, Hillel Yaffe Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2016
• Primary Completion (Actual): July 10, 2019
• Study Completion (Actual): July 10, 2019

Study Registration Dates

• First Submitted: March 9, 2019
• First Submitted That Met QC Criteria: March 23, 2019
• First Posted (Actual): March 27, 2019

Study Record Updates

• Last Update Posted (Actual): July 15, 2019
• Last Update Submitted That Met QC Criteria: July 11, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps
• Other Study ID Numbers: 0009-16-HYMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No