Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06566872
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-14
Brief Title:
Collecting Recorded Videos of Colonoscopy and Gastroscopy Tests for the Evaluation of the ME-APDS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Collecting Recorded Videos of Colonoscopy Gastroscopy Tests for the Evaluation of the Magentiq Eye Automatic Polyp Detection System ME-APDS Medical Device
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study shall mainly help to better evaluate the performance the ME-APDS device and secondly it may help the development of additional future versions of the ME-APDS
Primary endpoints
Clear video of the colon or the stomach or the esophagus achieved during the test
Acceptable colon or gastro test performance according to the standards criteria and regulations of the medical center of the trial
Secondary endpoints
A recorded video of at least 80 of the actual test duration
Primary endpoints
Clear video of the colon or the stomach or the esophagus achieved during the test
Acceptable colon or gastro test performance according to the standards criteria and regulations of the medical center of the trial
Secondary endpoints
A recorded video of at least 80 of the actual test duration
Detailed Description:
Primary objectives To support the offline evaluation in objective way of the performance of the ME-APDS device by testing the sensitivity and specificity and additional statistical parameters of its results achieved from running it on the collected recorded videos of Colonoscopy and Gastroscopy tests of the general population
Secondary objectives
Some of the data might be used also for the development of future versions of the ME-APDS
Each subject will pass regular colonoscopy andor gastroscopy test during which an external recording system connected to the secondary video out connector of the endoscopy processing device will record the video presented on the endoscopy device screen from the beginning of the test till its end The standard off-the shelf recording device will be connected to the endoscopy devices connector by the testing physician or hisher assistant during the tests preparation phase At the beginning of the test the testing physician or hisher assistant will press on recording start button and at end of the test the testing physician or hisher assistant will press on recording stop button At the end of each week the recorded video will be backed-up from the recording device to an external storage with two copies one for record keeping of the main investigator and one for the sponsoring entity
Pathology and procedure reports without any identification details will sent to the sponsor with the recorded video
Secondary objectives
Some of the data might be used also for the development of future versions of the ME-APDS
Each subject will pass regular colonoscopy andor gastroscopy test during which an external recording system connected to the secondary video out connector of the endoscopy processing device will record the video presented on the endoscopy device screen from the beginning of the test till its end The standard off-the shelf recording device will be connected to the endoscopy devices connector by the testing physician or hisher assistant during the tests preparation phase At the beginning of the test the testing physician or hisher assistant will press on recording start button and at end of the test the testing physician or hisher assistant will press on recording stop button At the end of each week the recorded video will be backed-up from the recording device to an external storage with two copies one for record keeping of the main investigator and one for the sponsoring entity
Pathology and procedure reports without any identification details will sent to the sponsor with the recorded video
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: