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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
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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:
Exclusion Criteria:
Any of the following colonoscopy related exclusion criteria will exclude the subject from the study:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Yael Kopelman, MD | Hillel Yaffe Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hillel Yaffe Medical Center | Hadera | 3810101 | Israel |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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