Artificial Intelligence Validation Trial for Polyp Detection: Pilot Study
Phase: NA
Conditions: Polyp of Colon
Sponsor: Universitaire Ziekenhuizen KU Leuven

 
 
 
 
 
 
 
Artificial Intelligence validation trial 
for polyp detection: Pilot study 
 
 
 
 
 
 
 
Date: 30-10-2019 
Study number: s59405 

AI validation study for polyp detection 
 
DO NOT USE A ZOOM CAP DURING THE COLONOSCOPY 
 
Any brand of endoscope can be used since we aim to develop a general system, 
independent of the brand or type. 
 
A GPU computer is connected to the Panasonic AG-MDR25P recorder. This recorder is 
directly connected via SDI to one of the SDI output ports of the processor. The computer will 
then in real-time analyse the video that is provided by the processor and show the polyp 
detections by overlaying a green bounding box on a separate screen.  
 
The endoscopist will perform his colonoscopy as always and he will only see the unaltered 
video feed from the endoscope processor. In the same room, a second human observer 
(who is experienced with the appearance of endoscopic video and polyps) will observe the 
second AI-enhanced screen connected to the computer. The procedure will then go as 
follows: 
 
1. Start recording with the Panasonic recorder from insertion of the endoscope. 
 
2. Take a still image when starting pullback from the caecum (to mark this point for easier 
analysis later). The second observer notes down the time indicated on the screen. 
 
3. After the caecum has been reached, the second observer will take note of the following 
events during the rest of the procedure (by marking it in the attached document): 
i. OBVIOUS FALSE POSITIVES 
The AI system gives a positive prediction but it is an obvious false positive 
(e.g. stool, biopsy forceps, coagulation tip, diverticulum, air bubble, …). These 
are nuisances caused by the system, but would never cause the endoscopist 
to take action. These detections are NOT communicated to the endoscopist. 
ii. OTHER FALSE POSITIVES 
The AI system gives a positive prediction but the endoscopist does not 
indicate the presence of a polyp. In this case, a polyp could potentially be 
missed. If this location disappears from the field-of-view of the endoscopist 
(i.e. out of the image), the second observer should notify the endoscopist and 
ask him/her to go back and inspect the location in question. Three outcomes 
are possible here: 
1. The location did not contain a polyp, so it was really a false positive. 
2. The location did contain a polyp, so it was an additional detection 
polyp by the system. 
3. The location could not be re-identified 
iii. FALSE NEGATIVES 
A polyp was found by the endoscopist, but the AI system never identified this 
location to contain a polyp. 
iv. TRUE POSITIVES 
The AI system and the endoscopist found the same polyp (irrespective of who 

was first). 
 
4. At the same time, the endoscopist performs the procedure as he would typically 
proceed until he gets interrupted by the second observer. He then tries to find the 
location as instructed by the second observer and proceeds after the location has been 
confirmed to contain a polyp or not. 
 
5. Stop recording when the whole procedure is over. 
 
Additional information needed: 
Please provide each video with the following information: 
- 
Number of polyps present in the video 
- 
For each polyp (in the order of appearance or by time indication of when they 
appeared) 
o Histological report conclusion 
o Size 
o Polypectomy type 
o Location 
o Morphology 
- 
Brand and type of endoscope that were used 

Statistical analysis plan: 
Pilot trial to determine: 
a) Performance of novel Artificial intelligence tool 
b) Power and sample size calculation for ideal set-up of large multicentre validation 
trial