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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Study to Evaluate the Diagnostic Performance of of MAGENTIQ-COLO During Colonoscopy.
At a glance
Conditions
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.
Study leadership
- Peter Siersema, MD, Ph.D. · PRINCIPAL_INVESTIGATOR · Erasmus Medical Center
Who to contact
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Inclusion
What this trial measures
- 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.