Collecting Recorded Videos of Colonoscopy Tests

Completed

• Conditions: Colon Polyp

• Registration Number: NCT03937063
• Lead Sponsor: Magentiq Eye LTD

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.

Study Timeline

• Study Start: 2019-03-22
• Study First Submitted: 2019-05-01
• Study First Submitted QC: 2019-05-01
• Study First Posted: 2019-05-03
• Primary Completion: 2020-02-12
• Study Completion: 2020-02-12
• Status Verified: 2020-03
• Last Update Submitted: 2020-11-13
• Last Update Posted: 2020-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recorded colonoscopy video which was verified by visual inspection to have sufficient high quality.	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.
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.	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.

Trial Locations

Locations (1)

Erlanger Health System; 🇺🇸 Chattanooga, Tennessee, United States