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

Starting soon · Not applicable

Conditions studied: Screening Colonoscopy, Surveillance Colonoscopy

In brief

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

Key facts

Study ID

NCT06568523

Run by

Magentiq Eye LTD

People needed

330

Starts

2024-09-15

Expected to finish

2025-08-31

Last updated by the study team

2024-08-23

Who can join

Age: 45 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• In situ polyps with known histology detected in a previous colonoscopy.
• No colorectal polyps detected during colonoscopy.
• Known or suspected inflammatory bowel disease.
• Polyposis syndrome (e.g., familial adenomatous polyposis, serrated polyposis).
• Non-hereditary polyposis syndromes (e.g. Lynch syndrome).
• History of chemotherapy or radiation therapy for colorectal lesions.
• Pregnancy.
• Has a referral for therapeutic procedure (i.e., endoscopic mucosal resection, intervention to stop a lower gastro-intestinal bleeding, etc.).
• Inability to undergo polypectomy (e.g., incorrect continued use of anticoagulants, comorbidities) or patient refusal, as assessed by the endoscopist.
• Inability to provide informed consent.

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Erlanger Health System — Chattanooga, Tennessee, United States
• Assuta — Haifa, Select State, Israel
• Hadassah Medical Organization — Jerusalem, Israel
• Erasmus Medical Center — Rotterdam, Netherlands

Full record on ClinicalTrials.gov

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