Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Nuovo Regina Margherita Hospital, Rome, Italy | UNKNOWN |
| Universitäts Medizin, Mainz, Germany | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Interventional prospective multicenter study: Polyp detection by an automated endoscopic tool as second observer during routine diagnostic colonoscopy
This is an investigator-initiated multicentre non-randomized prospective interventional trial to validate the performance of a novel state-of-the-art computer-aided diagnostic (CAD) tool in polyp detection implemented as second observer during routine diagnostic colonoscopy and to evaluate its feasibility in daily endoscopy. Patients referred for a screening surveillance or therapeutic colonoscopy will undergo a colonoscopy performed by an endoscopist with moderate to high adenoma detection rate (ADR > 20% and < 50%) while a second observer will follow the procedure on a bedside AI-tool to count the number of detections made by the AI system and categorize the results into positive or negative results as follows (1) true positive, (2) false negative, (3) other positive and (4) obvious false positive. When a doubtful detection is made by the AI-system, the second observer will ask to re-evaluate the indicated region. When the detection is clear, the endoscopist and second observer do not communicate. The entire procedure is recorded.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | Colonoscopy with AI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial intelligence for polyp detection | Diagnostic Test | Colonoscopy enriched with artificial intelligence tool developed for polyp detection, implemented as a second observer |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Raf Bisschops | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
We don't share any patient information with other researchers, nor when it's anonymized
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 30, 2019 | Apr 20, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 4, 2020 | May 5, 2020 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D001185 | Artificial Intelligence |
| ID | Term |
|---|---|
| D000465 | Algorithms |
| D055641 | Mathematical Concepts |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided