Collecting Recorded Videos of Colonoscopy Tests

Colon Polyp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03937063
• Other study ID #: 19-007
• Status: Completed
• Start date: March 22, 2019
• Est. completion date: February 12, 2020

Study information

• Verified date: March 2020
• Source: Magentiq Eye LTD
• Contact: n/a
• Is FDA regulated: No
• 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: 300
• Est. completion date: February 12, 2020
• Est. primary completion date: February 12, 2020
• 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 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

Related Conditions & MeSH terms

• Colon Polyp
• Polyps

Intervention

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.

Locations

Country	Name	City	State
United States	Erlanger Health System	Chattanooga	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Magentiq Eye LTD

Country where clinical trial is conducted

United States, 

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 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