Collecting Recorded Videos of Colonoscopy Screening Tests

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.

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Key information

Conditions

Colon Polyp Colonic Polyps Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hillel Yaffe Medical Center

Hadera, 3810101, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

Able to read, understand and provide written Informed Consent;
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

Treatment and study plan

Collecting recorded videos of Colonoscopy screening tests of the general population

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.

Primary outcomes

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 it does not include all the needed details about the polyps that were detected during the procedure.

Sponsors and collaborators

Lead sponsor

Magentiq Eye LTD

Industry

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Mar 27, 2019
Registry last updated: Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed