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Collecting Recorded Videos of Colonoscopy Tests

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03937063
Recruitment Status : Completed
First Posted : May 3, 2019
Last Update Posted : November 16, 2020
Sponsor:
Information provided by (Responsible Party):
Magentiq Eye LTD

Study Description
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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.

Condition or disease Intervention/treatment
Colon Polyp Other: Collecting recorded videos of Colonoscopy screening tests

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.

Study Design
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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Collecting Recorded Videos of Colonoscopy Screening Tests for the Evaluation of the Automatic Polyp Detection System (APDS) Medical Device
Actual Study Start Date : March 22, 2019
Actual Primary Completion Date : February 12, 2020
Actual Study Completion Date : February 12, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Groups and Cohorts
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Intervention Details:
  • Other: Collecting recorded videos of Colonoscopy screening tests
    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.

Outcome Measures
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Primary Outcome Measures :
  1. Recorded colonoscopy video which was verified by visual inspection to have sufficient high quality. [ Time Frame: Half an hour from the end of the procedure at which the video was recorded ]
    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 (low quality) to 10 (high quality). Only videos with rate above 7 are considered as having sufficient high quality.

  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. [ Time Frame: Half an hour from the end of the procedure for which the procedure report was filled-in ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937063


Locations
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United States, Tennessee
Erlanger Health System
Chattanooga, Tennessee, United States, 37403
Sponsors and Collaborators
Magentiq Eye LTD
More Information
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Responsible Party: Magentiq Eye LTD
ClinicalTrials.gov Identifier: NCT03937063    
Other Study ID Numbers: 19-007
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polyps
Pathological Conditions, Anatomical