Colon Polyp
Conditions
Keywords
Polyps
Brief summary
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 * Clear video of the colon or the stomach or the esophagus achieved during the test. * Acceptable colon or gastro test performance according to the standards, criteria, and regulations of the medical center of the trial. Secondary endpoints • A recorded video of at least 80% of the actual test duration.
Detailed description
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.
Interventions
DEVICEME-APDS
No Intervention
Sponsors
Magentiq Eye LTD
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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: 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/gastroscopy related
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | during colonoscopy and gastroscopy procedure | Clear video of the colon or the stomach or the esophagus achieved during the test. |
| 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 | Acceptable colon or gastro test performance according to the standards, criteria, and regulations of the medical center of the trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| A recorded video of at least 80% of the actual test duration. | during colonoscopy and gastroscopy procedure | A recorded video of at least 80% of the actual test duration. |
Countries
Israel
Contacts
Primary ContactDror Zur, Ph.D.
Outcome results
None listed