Evaluating the ME-APDS device through recorded videos of colonoscopy and gastroscopy tests
Collecting Recorded Videos of Colonoscopy Gastroscopy Tests for the Evaluation of the Magentiq Eye Automatic Polyp Detection System (ME-APDS) Medical Device
Magentiq Eye LTD · NCT06566872
This study is testing a new device called ME-APDS by looking at recorded videos from colonoscopy and gastroscopy tests to see how well it works.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Magentiq Eye LTD (industry) |
| Locations | 1 site (Be’er Ya‘aqov) |
| Trial ID | NCT06566872 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the performance of the ME-APDS device by collecting recorded videos from colonoscopy and gastroscopy tests. The primary objectives include assessing the sensitivity and specificity of the device based on the recorded videos, while secondary objectives may contribute to the development of future versions of the device. Participants will undergo standard colonoscopy and/or gastroscopy procedures, during which their tests will be recorded for analysis. The study will ensure that all recordings meet the established medical standards and criteria.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are scheduled for routine colonoscopy or gastroscopy procedures.
Not a fit: Patients with bleeding disorders, terminal illnesses, or life-threatening malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy and effectiveness of the ME-APDS device in detecting colon polyps.
How similar studies have performed: While this approach is focused on evaluating a specific device, similar studies utilizing recorded endoscopic procedures have shown promise in improving diagnostic accuracy.
Eligibility criteria
Show full inclusion / exclusion criteria
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: 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/gastroscopy related exclusion criteria will exclude the subject from the study: * Bleeding disorder or unacceptable risk of bleeding * Terminal illness or life threatening malignancy
Where this trial is running
Be’er Ya‘aqov
- Department of Gastroenterology, Shamir Medical Center, Israel — Be’er Ya‘aqov, Israel (RECRUITING)
Study contacts
- Principal investigator: Haim Shirin, Prof. — Gastroenterology Department of Shamir Medical Center, Israel
- Study coordinator: Dror Zur, Ph.D.
- Email: dror@magentiq.com
- Phone: +972(54)7555922
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colon Polyp, Polyps