Colon PolypNCT06566872
Collecting Recorded Videos of Colonoscopy and Gastroscopy Tests for the Evaluation of the (ME-APDS).
An observational study of Colon Polyp, run by Magentiq Eye LTD at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Polyp
- What is being tested?
- ME-APDS
- Type of treatment
- Medical device
- How many people
- 700 participants
- Where
- 1 siteIsrael
- Study dates
- 16 May 2022to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Subjects shall be recruited by the investigator from within the investigator's patient population of colonoscopy and Gastroscopy. In this study one site will participate and enroll not less than 250 patients and up to 700 subjects according to the inclusion/exclusion criteria. Each subject (not less than 250 patients and up to 700 subjects) included will pass one regular colonoscopy and/or gastroscopy test which will be recorded in the way which is described above. Enrolled subjects that did not complete the full course of the study will be replaced. Eligibility Each subject will be evaluated by the Investigator to assess his/ her suitability for entry into this study according to the Inclusion and Exclusion criteria.
Who may be able to join
- 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:
- Able to read, understand and provide written Informed Consent;
- Females or males - older than 18 years old
Who cannot join
- Any of the following colonoscopy/gastroscopy related exclusion criteria will exclude the subject from the study:
- Bleeding disorder or unacceptable risk of bleeding
- Terminal illness or life threatening malignancy
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Shamir Medical Center, Israel
Be’er Ya‘aqov
Haim Shirin, Prof, +972(0)89779655
About this study
Official title: Collecting Recorded Videos of Colonoscopy Gastroscopy Tests for the Evaluation of the Magentiq Eye Automatic Polyp Detection System (ME-APDS) Medical Device
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.
Read the 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 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.
- Conditions
- Colon Polyp
- Being tested
- ME-APDS
- Keywords
- Polyps
- Medical subject headings
- Colonic Polyps, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ME-APDSDevice
Also called Automatic Polyp Detection System (ME-APDS) Medical Device
No Intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Clear video of the colon or the stomach or the esophagus achieved during the test.
Measured: 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.
Acceptable colon or gastro test performance according to the standards, criteria, and regulations of the medical center of the trial.
Measured: during colonoscopy and gastroscopy procedure
Secondary outcomes (1)
A recorded video of at least 80% of the actual test duration.
A recorded video of at least 80% of the actual test duration.
Measured: during colonoscopy and gastroscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start16 May 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon PolypStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Magentiq Eye LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Haim Shirin, Prof., Principal investigator, Gastroenterology Department of Shamir Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566872
- Sponsor's protocol ID
- CL-0041
- Status last verified
- Jul 2024
- First submitted
- 14 Jul 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collecting Recorded Videos of Colonoscopy Gastroscopy Tests for the Evaluation of the Magentiq Eye Automatic Polyp Detection System (ME-APDS) Medical Device
- ClinicalTrials.gov ID
- NCT06566872
- Acronym / sponsor ID
- CL-0041
- Conditions
- Colon Polyp
- Keywords
- Polyps
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Magentiq Eye LTDIndustry (pharma, biotech, devices)
- Study start
- 16 May 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects shall be recruited by the investigator from within the investigator's patient population of colonoscopy and Gastroscopy. In this study one site will participate and enroll not less than 250 patients and up to 700 subjects according to the inclusion/exclusion criteria. Each subject (not less than 250 patients and up to 700 subjects) included will pass one regular colonoscopy and/or gastroscopy test which will be recorded in the way which is described above. Enrolled subjects that did not complete the full course of the study will be replaced. Eligibility Each subject will be evaluated by the Investigator to assess his/ her suitability for entry into this study according to the Inclusion and Exclusion criteria.
Key inclusion criteria (3 listed)
- 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:
- Able to read, understand and provide written Informed Consent;
- Females or males - older than 18 years old
Key exclusion criteria (3 listed)
- Any of the following colonoscopy/gastroscopy related exclusion criteria will exclude the subject from the study:
- Bleeding disorder or unacceptable risk of bleeding
- Terminal illness or life threatening malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ME-APDSAlso: Automatic Polyp Detection System (ME-APDS) Medical DeviceNo Intervention | Device | – |
Primary outcome
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.
Time frame: during colonoscopy and gastroscopy procedure
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.
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.
1 secondary outcome
A recorded video of at least 80% of the actual test duration.
Time frame: during colonoscopy and gastroscopy procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haim Shirin, Prof. principal investigator
Gastroenterology Department of Shamir Medical Center, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Polyp, run by Magentiq Eye LTD at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dror Zur, Ph.D. (+972(54)7555922, dror@magentiq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: during colonoscopy and gastroscopy procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.