Polyp of Colon Clinical Trial
Official title:
Artificial Intelligence Validation Trial for Polyp Detection: Pilot Study
NCT number | NCT04378660 |
Other study ID # | s59405 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 30, 2019 |
Est. completion date | April 18, 2020 |
Verified date | April 2020 |
Source | Universitaire Ziekenhuizen Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Interventional prospective multicenter study: Polyp detection by an automated endoscopic tool as second observer during routine diagnostic colonoscopy
Status | Completed |
Enrollment | 357 |
Est. completion date | April 18, 2020 |
Est. primary completion date | April 18, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: - > 18 years - Diagnostic or screening colonoscopy - Therapeutic colonoscopy Exclusion Criteria: - Inability to give informed consent by the patient or legal representative - < 18 years old - Any contraindication for colonoscopy or biopsies of the colon - Uncontrolled coagulopathy - Confirmed diagnosis of inflammatory bowel disease - Short bowel or ileostomy - Pregnancy |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospitals Leuven | Leuven | Vlaams-Brabant |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen Leuven | Nuovo Regina Margherita Hospital, Rome, Italy, Universitäts Medizin, Mainz, Germany |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic accuracy of the novel AI system compared to endoscopic diagnosis as gold standard | Determination of the diagnostic accuracy of the novel AI system as second observer | 4 months | |
Secondary | Endoscopist's polyp miss rate as number of extra AI detections | Determination of the AI system's precision and extra value as second observer | 4 months |
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