Status:
NOT_YET_RECRUITING
Study to Evaluate the Diagnostic Performance of of MAGENTIQ-COLO During Colonoscopy.
Lead Sponsor:
Magentiq Eye LTD
Conditions:
Screening Colonoscopy
Surveillance Colonoscopy
Eligibility:
All Genders
45-80 years
Phase:
NA
Brief Summary
This is an international, multicenter, study to evaluate the diagnostic performance of the CADx polyp sizing modality of the MAGENTIQ-COLO.
Detailed Description
Colonoscopy is the gold standard for the detection and removal of premalignant colorectal polyps. Recommended post-polypectomy surveillance intervals are primarily based on pathological diagnosis and ...
Eligibility Criteria
Inclusion
- Individuals aged ≥45 - ≤80 years old, who are scheduled for non-iFOBT screening or surveillance colonoscopy.
Exclusion
- 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.
Key Trial Info
Start Date :
September 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT06568523
Start Date
September 15 2024
End Date
August 31 2025
Last Update
August 23 2024
Active Locations (5)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21202
2
Erlanger Health System
Chattanooga, Tennessee, United States, 37403
3
Assuta
Haifa, Select State, Israel
4
Hadassah Medical Organization
Jerusalem, Israel, 91120