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The study shall mainly help to better evaluate the performance the ME-APDS device and secondly it may help the development of additional future versions of the ME-APDS.
Primary endpoints
Secondary endpoints
• A recorded video of at least 80% of the actual test duration.
Primary objectives • To support the offline evaluation, in objective way, of the performance of the ME-APDS device by testing the sensitivity and specificity and additional statistical parameters of its results achieved from running it on the collected recorded videos of Colonoscopy and Gastroscopy tests of the general population.
Secondary objectives
• Some of the data might be used also for the development of future versions of the ME-APDS
Each subject will pass regular colonoscopy and/or gastroscopy test during which an external recording system connected to the secondary "video out" connector of the endoscopy processing device will record the video presented on the endoscopy device screen from the beginning of the test till its end. The standard off-the shelf recording device will be connected to the endoscopy device's connector by the testing physician or his/her assistant during the test's preparation phase. At the beginning of the test the testing physician or his/her assistant will press on recording start button, and at end of the test, the testing physician or his/her assistant will press on recording stop button. At the end of each week, the recorded video will be backed-up from the recording device to an external storage with two copies, one for record keeping of the main investigator, and one for the sponsoring entity.
Pathology and procedure reports without any identification details will sent to the sponsor with the recorded video.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ME-APDS | Device | No Intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| To support the offline evaluation, in objective way, of the performance of the ME-APDS device by testing the sensitivity and specificity and additional statistical parameters. | Clear video of the colon or the stomach or the esophagus achieved during the test. | during colonoscopy and gastroscopy procedure |
| Acceptable colon or gastro test performance according to the standards, criteria, and regulations of the medical center of the trial. | Acceptable colon or gastro test performance according to the standards, criteria, and regulations of the medical center of the trial. | during colonoscopy and gastroscopy procedure |
| Measure | Description | Time Frame |
|---|---|---|
| A recorded video of at least 80% of the actual test duration. | A recorded video of at least 80% of the actual test duration. | during colonoscopy and gastroscopy procedure |
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Inclusion Criteria:
Subjects must meet all the - criteria related to regular colonoscopy and/or gastroscopy according to the standard of care at the Gastroenterolgy Department of the selected center, _In addition the following - criteria have to be met to be eligible for the study:
Exclusion Criteria:
Any of the following colonoscopy/gastroscopy 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 and Gastroscopy. 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 and/or gastroscopy 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.
Eligibility Each subject will be evaluated by the Investigator to assess his/ her suitability for entry into this study according to the Inclusion and Exclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dror Zur, Ph.D. | Contact | +972(54)7555922 | dror@magentiq.com |
| Name | Affiliation | Role |
|---|---|---|
| Haim Shirin, Prof. | Gastroenterology Department of Shamir Medical Center, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, Shamir Medical Center, Israel | Recruiting | Be’er Ya‘aqov | Israel |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| D011127 | Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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