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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03891290
Other study ID # 0009-16-HYMC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 21, 2016
Est. completion date July 10, 2019

Study information

Verified date July 2019
Source Magentiq Eye LTD
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 166
Est. completion date July 10, 2019
Est. primary completion date July 10, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

Subjects must meet all the criteria related to regular colonoscopy according to the standard of care at the Gastroenterolgy Department of the selected center. In addation, 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:

- Bleeding disorder or unacceptable risk of bleeding

- Terminal illness or life threatening malignancy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Collecting recorded videos of Colonoscopy screening tests of the general population
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.

Locations

Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)

Lead Sponsor Collaborator
Magentiq Eye LTD

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 (low quality) to 10 (high quality). Only videos with rate above 7 are considered as having sufficient high quality. Half an hour from the end of the procedure at which the video was recorded.
Primary 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 it does not include all the needed details about the polyps that were detected during the procedure. Half an hour from the end of the procedure for which the procedure report was filled-in.
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