Collecting Recorded Videos of Colonoscopy

NCT03891251 | Recruiting

• 1 other identifier: 0493-18-HMO
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Polyp

Outcome Measures

Primary Outcomes (2)

• 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 (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.

  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 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.

  Half an hour from the end of the procedure for which the procedure report was filled-in.

Interventions

Collecting recorded videos of Colonoscopy screening tests OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Bleeding disorder or unacceptable risk of bleeding
• Terminal illness or life threatening malignancy

Sponsors & Collaborators

• Magentiq Eye LTD: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

RECRUITING

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Harold Jacob, MD

  Senior Gastroenterologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dror Zur, Ph.D.

CONTACT

+972(54)7555922; dror@magentiq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2019
• First Posted: March 27, 2019
• Study Start: December 19, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)