Collecting Recorded Videos of Colonoscopy and Gastroscopy Tests for the Evaluation of the (ME-APDS).
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 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.
Eligibility criteria
This trial does not accept 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 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
ME-APDS
DeviceNo Intervention
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
during colonoscopy and gastroscopy procedure2
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.
Time frame
during colonoscopy and gastroscopy procedureSecondary outcomes
1
A recorded video of at least 80% of the actual test duration.
A recorded video of at least 80% of the actual test duration.
Time frame
during colonoscopy and gastroscopy procedureSponsors and contacts
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Source ClinicalTrials.gov