Actively Recruiting
Collecting Recorded Videos of Colonoscopy Screening Tests for the Evaluation of the Automatic Polyp Detection System (APDS) Medical Device
Led by Magentiq Eye LTD · Updated on 2025-10-06
700
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the Automatic Polyp Detection System (APDS) device to evaluate its performance in detecting colon polyps using recorded videos from colonoscopy screening tests in the general population. The main goal is to objectively assess the usability of the future alpha version of this device by testing its sensitivity and specificity. Additionally, the study plans to install a beta version of the device in a medical center's Gastroenterology institute to evaluate physician satisfaction as a follow-up phase. The study involves collecting recorded colonoscopy videos that meet quality standards and procedure reports with detailed polyp information. These videos and reports will be analyzed using the APDS device to assess its detection accuracy. When the device reaches the beta version stage, it will be installed in a clinical setting for further evaluation by physicians. This observational study does not involve treatment but focuses on the device's diagnostic performance. Participants will undergo standard colonoscopy screening according to regular care at the Gastroenterology Department. The study collects high-quality recorded videos and de-identified procedure reports within half an hour of the colonoscopy. Data collection includes visual inspections of videos and reports for quality and detail. The study measures the device’s performance accuracy, including sensitivity and specificity for polyp detection. Participants must provide informed consent and meet age criteria, and the study includes follow-up to evaluate device usability and physician feedback.
CONDITIONS
Brief Title
Collecting Recorded Videos of Colonoscopy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled for regular colonoscopy according to standard care at the Gastroenterology Department
- Able to read, understand, and provide written informed consent
- Male or female aged 18 years or older
You will not qualify if you...
- Bleeding disorder or unacceptable risk of bleeding
- Terminal illness or life-threatening malignancy that prevents participation in the study procedures or colonoscopy screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) during their scheduled colonoscopy
Duration - Day of colonoscopy
Participants undergo a routine colonoscopy as part of their standard care, during which recorded videos of the procedure are collected for evaluation.
1 visit (in-person) for the colonoscopy procedure
Duration - Up to 30 minutes after the procedure
Collected videos and procedure reports are analyzed to evaluate the Automatic Polyp Detection System (APDS) device performance.
No additional visits required; analysis is performed on recorded data
Trial Site Locations
Total: 1 location
1
Hadassah Medical Organization
Jerusalem, Israel, 91120
Actively Recruiting
Research Team
D
Dror Zur, Ph.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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