Back to resultsArtificial Intelligence (AI) Validation Study for Polyp Detection
Primary Purpose
Polyp of Colon
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Artificial intelligence for polyp detection
Sponsored by
About this trial
This is an interventional diagnostic trial for Polyp of Colon focused on measuring Colonic polyp, Artificial intelligence, Second observer
Eligibility Criteria
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
Sites / Locations
- University Hospitals Leuven
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention arm
Arm Description
Colonoscopy with AI
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Endoscopist's polyp miss rate as number of extra AI detections
Determination of the AI system's precision and extra value as second observer
Full Information
NCT ID
NCT04378660
First Posted
April 20, 2020
Last Updated
May 5, 2020
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Nuovo Regina Margherita Hospital, Rome, Italy, Universitäts Medizin, Mainz, Germany
1. Study Identification
Unique Protocol Identification Number
NCT04378660
Brief Title
Artificial Intelligence (AI) Validation Study for Polyp Detection
Official Title
Artificial Intelligence Validation Trial for Polyp Detection: Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
October 30, 2019 (Actual)
Primary Completion Date
April 18, 2020 (Actual)
Study Completion Date
April 18, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Nuovo Regina Margherita Hospital, Rome, Italy, Universitäts Medizin, Mainz, Germany
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Interventional prospective multicenter study: Polyp detection by an automated endoscopic tool as second observer during routine diagnostic colonoscopy
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyp of Colon
Keywords
Colonic polyp, Artificial intelligence, Second observer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
357 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Colonoscopy with AI
Intervention Type
Diagnostic Test
Intervention Name(s)
Artificial intelligence for polyp detection
Intervention Description
Colonoscopy enriched with artificial intelligence tool developed for polyp detection, implemented as a second observer
Primary Outcome Measure Information:
Title
Diagnostic accuracy of the novel AI system compared to endoscopic diagnosis as gold standard
Description
Determination of the diagnostic accuracy of the novel AI system as second observer
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Endoscopist's polyp miss rate as number of extra AI detections
Description
Determination of the AI system's precision and extra value as second observer
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raf Bisschops
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We don't share any patient information with other researchers, nor when it's anonymized
Learn more about this trial
Artificial Intelligence (AI) Validation Study for Polyp Detection
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