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

Not Applicable

Not yet recruiting

• Conditions: Screening Colonoscopy; Surveillance Colonoscopy

• Registration Number: NCT06568523
• Lead Sponsor: Magentiq Eye LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-21
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

Inclusion Criteria:<br><br> - Individuals aged =45 - =80 years old, who are scheduled for non-iFOBT screening or<br> surveillance colonoscopy.<br><br>Exclusion Criteria:<br><br> 1. In situ polyps with known histology detected in a previous colonoscopy.<br><br> 2. No colorectal polyps detected during colonoscopy.<br><br> 3. Known or suspected inflammatory bowel disease.<br><br> 4. Polyposis syndrome (e.g., familial adenomatous polyposis, serrated polyposis).<br><br> 5. Non-hereditary polyposis syndromes (e.g. Lynch syndrome).<br><br> 6. History of chemotherapy or radiation therapy for colorectal lesions.<br><br> 7. Pregnancy.<br><br> 8. Has a referral for therapeutic procedure (i.e., endoscopic mucosal resection,<br> intervention to stop a lower gastro-intestinal bleeding, etc.).<br><br> 9. Inability to undergo polypectomy (e.g., incorrect continued use of anticoagulants,<br> comorbidities) or patient refusal, as assessed by the endoscopist.<br><br> 10. Inability to provide informed consent.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
CADx size measurement vs. open biopsy forceps;ESGE 'resect-and-discard' & 'leave-in-situ'