Study to Evaluate MAGENTIQ-COLO During Colonoscopy

This study is evaluating a new tool called MAGENTIQ-COLO, which uses computer-aided diagnosis (CADx) during a colonoscopy. The goal is to see how well MAGENTIQ-COLO can accurately measure the size of polyps (growths) in your colon, specifically whether they are small (diminutive, 5mm or less) or larger (non-diminutive, over 5mm). This is important because polyp size helps doctors decide how often you need future colonoscopies. You might be able to join if you are between 45 and 80 years old and are scheduled for a screening or surveillance colonoscopy. The study aims to enroll 330 people. Success for this study means MAGENTIQ-COLO can accurately size polyps compared to the standard method. The current recruitment status is unclear.

Study design
This is an interventional study that will enroll 330 participants. All participants will undergo the same study procedures, and there is no randomization.
What's involved
You will undergo a colonoscopy procedure where the MAGENTIQ-COLO device will be used. The primary endpoint is measured during this procedure.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured during the colonoscopy procedure, so no long-term follow-up is specified.

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NCT06568523

Study to Evaluate the Diagnostic Performance of of MAGENTIQ-COLO During Colonoscopy.

UNKNOWN
NAAges 45–80InterventionalScreening
Magentiq Eye LTD
~330 participants
Updated 2024-08-23 on ClinicalTrials.gov
What's tested:MAGENTIQ-COLO.

At a glance

Recruiting sites
0 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over During the Colonoscopy Procedure
Screening Colonoscopy
Surveillance Colonoscopy

NCT06568523

Where you'd take part

This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Assuta

    Haifa, Select State, Israelno site contact published

  • Erasmus Medical Center

    Rotterdam, Netherlandsno site contact published

  • Erlanger Health System

    Chattanooga, Tennesseeno site contact published

  • Hadassah Medical Organization

    Jerusalem, Israelno site contact published

  • Johns Hopkins Hospital

    Baltimore, Marylandno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Peter Siersema, MD, Ph.D. · PRINCIPAL_INVESTIGATOR · Erasmus Medical Center

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Eligibility criteria

Inclusion

Individuals aged ≥45 - ≤80 years old, who are scheduled for non-iFOBT screening or surveillance colonoscopy.
  • 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.During the Colonoscopy Procedure

    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, which is the size classification of the colorectal polyp using open biopsy forceps, or polypectomy snare, of known diameter. The diagnostic performance of the CADx-assisted optical diagnosis to correctly classify colorectal polyps as diminutive (≤5mm) or non-diminutive (\>5mm) compared to size classification using open biopsy forceps, or polypectomy snare, of known diameter. This will be measured by the sensitivity and specificity of the CADx-assisted optical diagnosis compared to an expected minimum of 70% sensitivity and 70% specificity.