Collecting Recorded Videos of Colonoscopy
ConditionColon Polyp
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMagentiq Eye LTD
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Able to read, understand and provide written Informed Consent;
Females or males - older than 18 years old
Disqualifiers
Bleeding disorder or unacceptable risk of bleeding
Terminal illness or life threatening malignancy
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Collecting recorded videos of Colonoscopy screening tests
Other interventionTo 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.2
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.Sponsors and contacts
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Source ClinicalTrials.gov