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Patients will undergo colonoscopy with the real-time use of the MAGENTIQ-COLO technology. for Screening Colonoscopy

N/A
Waitlist Available
Led By Peter Siersema, MD, Ph.D.
Research Sponsored by Magentiq Eye LTD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Individuals aged ≥45 - ≤80 years old, who are scheduled for non-iFOBT screening or surveillance colonoscopy.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the colonoscopy procedure
Awards & highlights

Summary

This is an international, multicenter, study to evaluate the diagnostic performance of the CADx polyp sizing modality of the MAGENTIQ-COLO.

Who is the study for?
This trial is for individuals undergoing a screening colonoscopy. Specific eligibility criteria are not provided, but typically participants would need to be of an age and condition where a colonoscopy is recommended.
What is being tested?
The study focuses on evaluating the diagnostic performance of MAGENTIQ-COLO, which is a computer-aided detection (CADx) system designed to assist in polyp sizing during colonoscopies.
What are the potential side effects?
Since MAGENTIQ-COLO is a diagnostic tool used during colonoscopy and not a drug or invasive treatment, it does not have direct side effects. However, standard risks associated with colonoscopies still apply.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the colonoscopy procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and during the colonoscopy procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The sensitivity of the CADx-assisted optical diagnosis in classifying colorectal polyps as diminutive (≤5mm) or non-diminutive (>5mm) compared to the reference gold standard.
Secondary study objectives
CADx size measurement vs. open biopsy forceps
ESGE 'resect-and-discard' & 'leave-in-situ'
Other study objectives
ASGE PIVI-1 Post-polypectomy surveillance interval
ASGE PIVI-2 NPV of neoplastic rectosigmoid polyps
Rate of high-confidence diagnoses

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients will undergo colonoscopy with the real-time use of the MAGENTIQ-COLO technology.Experimental Treatment1 Intervention
Endoscopists will assess all colorectal polyps detected during colonoscopy with and without the MAGENTIQ-COLO.

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Who is running the clinical trial?

Magentiq Eye LTDLead Sponsor
5 Previous Clinical Trials
2,818 Total Patients Enrolled
1 Trials studying Screening Colonoscopy
952 Patients Enrolled for Screening Colonoscopy
Peter Siersema, MD, Ph.D.Principal InvestigatorErasmus Medical Center
1 Previous Clinical Trials
952 Total Patients Enrolled
1 Trials studying Screening Colonoscopy
952 Patients Enrolled for Screening Colonoscopy
~220 spots leftby Aug 2025
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