Clinical trial NCT03937063: Collecting Recorded Videos of Colonoscopy Tests
Official title: Collecting Recorded Videos of Colonoscopy Screening Tests for the Evaluation of the Automatic Polyp Detection System (APDS) Medical Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Polyp
Lead sponsor: Magentiq Eye LTD
Sponsor class: INDUSTRY
First posted: 2019-05-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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 200 patients and up to 300 subjects according to the inclusion/exclusion criteria. Each subject (not less than 200 patients and up to 300 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

Brief summary: 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.

Detailed description: 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: When the APDS would be ready for field installation (Beta Version), to install it in the Gastroenterology institute of the medical center, in order to evaluate, as part of a continuation study, the physicians satisfaction from the APDS performance.

Eligibility criteria: Inclusion Criteria:

* 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:

  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 related exclusion criteria will exclude the subject from the study:

  1. Bleeding disorder or unacceptable risk of bleeding
  2. Terminal illness or life threatening malignancy

Primary outcomes:
measure: Recorded colonoscopy video which was verified by visual inspection to have sufficient high quality.
timeFrame: Half an hour from the end of the procedure at which the video was recorded
measure: 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.
timeFrame: Half an hour from the end of the procedure for which the procedure report was filled-in
Secondary outcomes:
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: Erlanger Health System
state: Tennessee
Study officials:
References: