Status:
COMPLETED
Characterization of Colorectal Neoplasia
Lead Sponsor:
Nuovo Regina Margherita Hospital
Conditions:
Colonic Polyp
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
This is a post-marketing, single-arm, prospective study investigating the use of GI Genius CADx device in the real-time characterization of colorectal polyps (i.e. prediction of their histology during...
Eligibility Criteria
Inclusion
- Patients aged 40 years or older undergoing screening colonoscopy for CRC
- Ability to provide written, informed consent (approved by EC) and understand the responsibilities of trial participation
Exclusion
- subjects at high risk for colorectal cancer
- subjects with a personal history of CRC, IBD or hereditary polyposis or non-polyposis syndromes
- patients with previous resection of the sigmoid rectum
- patients on anticoagulant therapy, which precludes resection / removal operations due to histopathological findings
- patients who perform an emergency colonoscopy
Key Trial Info
Start Date :
May 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2021
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT04884581
Start Date
May 12 2021
End Date
August 5 2021
Last Update
August 6 2021
Active Locations (1)
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1
Nuovo Regina Margherita
Roma, Italy