Status:
COMPLETED
Usefulness of GI-GENIUS in FIT-based Colorectal Cancer Screening Program.
Lead Sponsor:
Asociación Española de Gastroenterología
Collaborating Sponsors:
Medtronic
Conditions:
Colorectal Neoplasms
Intestinal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Deep learning technology has an increasing role in medical image applications and, recently, an artificial intelligence device has been developed and commercialized by Medtronic for identification of ...
Eligibility Criteria
Inclusion
- Individuals with a positive result in fecal immunochemical test within the population-based colorectal cancer screening program.
- Complete colonoscopy with cecal intubation.
- Inform consent signed.
Exclusion
- Personal history of colorectal cancer.
- Family history of colorectal cancer: ≥2 FDR or ≥1 FDR diagnosed before 50 years of age.
- Family history of hereditary colorectal cancer syndromes: Lynch syndrome, FAP, etc.
- Personal history of inflammatory bowel disease.
- Terminal illness.
- Personal history of total proctocolectomy.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
3400 Patients enrolled
Trial Details
Trial ID
NCT04673136
Start Date
April 1 2021
End Date
March 31 2022
Last Update
April 8 2022
Active Locations (6)
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1
Hospital General Universitario de Alicante
Alicante, Spain, 03010
2
Hospital Clinic Barcelona
Barcelona, Spain
3
Complexo Hospitalario de Ourense
Ourense, Spain
4
Hospital Universitario Central de Asturias
Oviedo, Spain