An observational study in Colon Polyp, sponsored by Magentiq Eye LTD. Recruiting at 1 site in Israel. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-06.
Sponsored by Magentiq Eye LTD · Observational
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
377 studies on the registry are indexed under Colonic Polyps; 57 are open to participants now.
This study's planned enrollment of 700 is above the median of 411 across 115 observational studies indexed under Colonic Polyps.
Browse Colonic Polyps studies →Magentiq Eye LTD is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Any of the following colonoscopy related exclusion criteria will exclude the subject from the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 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.
Time frame: Half an hour from the end of the procedure for which the procedure report was filled-in.
Plan to share: No
No publications or documents are linked to this record.
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