NCT03937063

Collecting Recorded Videos of Colonoscopy Tests

Collecting Recorded Videos of Colonoscopy Screening Tests for the Evaluation of the Automatic Polyp Detection System (APDS) Medical Device

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: Magentiq Eye LTD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Colon Polyp

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-03-22
• Primary completion: 2020-02-12
• Completion: 2020-02-12
• First posted: 2019-05-03
• Last updated: 2020-11-16

Locations

1 site across 1 country: United States