Department of Gastroenterology, Shamir Medical Center, Israel
Be’er Ya‘aqov, Israel
Location status: Recruiting
NCT Number: NCT06566872
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Be’er Ya‘aqov, Israel
Location status: Recruiting
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
Each subject will pass regular colonoscopy and/or 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 device's connector by the testing physician or his/her assistant during the test's preparation phase. At the beginning of the test the testing physician or his/her assistant will press on recording start button, and at end of the test, the testing physician or his/her 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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Subjects must meet all the - criteria related to regular colonoscopy and/or gastroscopy according to the standard of care at the Gastroenterolgy Department of the selected center, _In addition the following - criteria have to be met to be eligible for the study:
Exclusion criteria
Any of the following colonoscopy/gastroscopy related exclusion criteria will exclude the subject from the study:
No Intervention
Other names: Automatic Polyp Detection System (ME-APDS) Medical Device
Time frame: during colonoscopy and gastroscopy procedure
Clear video of the colon or the stomach or the esophagus achieved during the test.
Time frame: during colonoscopy and gastroscopy procedure
Acceptable colon or gastro test performance according to the standards, criteria, and regulations of the medical center of the trial.
Time frame: during colonoscopy and gastroscopy procedure
A recorded video of at least 80% of the actual test duration.
Contact information is provided by the study sponsor or research team.
Magentiq Eye LTD
Industry
Collecting Recorded Videos of Colonoscopy Gastroscopy Tests for the Evaluation of the Magentiq Eye Automatic Polyp Detection System (ME-APDS) Medical Device
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05064124
Adenoma Colon, Colon Polyp
London, United Kingdom
View Trial DetailsNCT04369053
Adenoma, Colon Cancer
Birmingham, Alabama, United States
View Trial DetailsNCT05551052
Adenoma, Adenomas Colon
Chula Vista, California, United States
View Trial DetailsNCT04889352
Colo-rectal Cancer, Colon Polyp
Winnipeg, Manitoba, Canada
View Trial Details