Evaluating a new device for detecting colon polyps using recorded colonoscopy videos
Collecting Recorded Videos of Colonoscopy Screening Tests for the Evaluation of the Automatic Polyp Detection System (APDS) Medical Device
This study is testing a new device that uses recorded colonoscopy videos to see how well it can find colon polyps in people getting screened.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Magentiq Eye LTD Industry-sponsored |
| Locations | 1 site (Jerusalem) |
| Trial ID | NCT03891251 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the performance of the APDS device by analyzing recorded videos from colonoscopy screenings. The primary objective is to evaluate the device's sensitivity and specificity in detecting colon polyps. Additionally, once the device is ready for field installation, a continuation study will assess physician satisfaction with its performance in a clinical setting. The study will involve collecting these recorded videos from the general population undergoing routine colonoscopy.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are undergoing routine colonoscopy as part of standard care.
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 of colon polyp detection, leading to improved patient outcomes.
How similar studies have performed: While this approach is innovative, similar studies evaluating device performance in colonoscopy have shown promise in enhancing detection rates.
Eligibility criteria
Show full inclusion / exclusion criteria
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: * Bleeding disorder or unacceptable risk of bleeding * Terminal illness or life threatening malignancy
Where this trial is running
Jerusalem
- Hadassah Medical Organization — Jerusalem, Israel (Recruiting)
Study contacts
- Principal investigator: Harold Jacob, MD — Senior Gastroenterologist
- 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.