Detection of Colonic Polyps Via a Large Scale AI System
Phase: NA
Conditions: Colonic Polyp
Sponsor: Shaare Zedek Medical Center

Cover Page 
Date of last modification of this document: February 9th 2021. 
The original protocol was written in February 2020. 
Title: Detection of Colonic Polyps Via a Large Scale Artificial Intelligence (AI) System 
ClinicalTrials.gov ID: NCT04693078 
 
Authors: 
Dan M. Livovsky1,*, Danny Veikherman2, Tomer Golany2, Amit Aides2, Valentin 
Dashinski2, Nadav Rabani2, David Ben Shimol3, Yochai Blau2, Liran Katzir2, Ilan 
Shimshoni4, Yun Liu3, Ori Segol5, Eran Goldin1, Greg Corrado3, Jesse Lachter6,7, 
Yossi Matias2, Ehud Rivlin2, Daniel Freedman2 
 
Affiliations: 
1 Faculty of Medicine, Hebrew University of Jerusalem, Israel; Digestive Diseases 
Institute, Shaare Zedek Medical Center, Jerusalem, Israel 
2 Google Research, Israel 
3 Google Health, USA 
4 Department of Information Systems, University of Haifa (work performed while at 
Google Research, Israel) 
5 Carmel Medical Center, Haifa, Israel 
6 Technion – Israel Institute of Technology Faculty of Medicine, Haifa, Israel 
7 United Healthcare Services, Israel 
 
 
 
 
 
 

Clinical Study Protocol Synopsis  
 
Detection of Colonic Polyps Via a Large Scale Artificial Intelligence (AI) System   
 
Study Objective: 
To measure the accuracy of the real-time AI system in detecting colorectal polyps 
 
Background: 
Adenomatous Polyps detection is ultimate goal of screening colonoscopy, the gold 
standard for colorectal cancer detection yet over 10% of large adenomatous polyps 
are missed. The use of computerized detection software (as the case in radiology) 
could potentially improve adenoma detection rate (ADR). A 1% increase in ADR is 
associated with a 3% reduction in the risk of post-colonoscopy colorectal cancer. The 
propostes system is a real time detection device designed to draw the Colonscopists 
attention to potential lesions. 
 
The device system is based on an Artificial Intelligence algorithm  to automatically 
annotate findings in real-time that are suggestive of lesions. It is installed on a 
standalone cart including a dedicated computer and screen that receives the real 
time video from the Colonosocopy system.  
Findings are displayed side-by-side on the dedicated EVA screen annotated (visual 
feedback) and the user is also notified (audio feedback). 
 
Study Design Prospective, single center, open-label, exploratory study. 
 
Study Endpoints 
Primary endpoints:  
(a) number of additional polyps detected by DEEP2 in real time  
(b) safety.  
 
Secondary endpoints:  
(c) Polyp detection rate (i.e. percentage of colonoscopies where > 1 polyps were 
detected);  
(d) Rate of false alarms per colonoscopy (False positive and false negative);  
(e) User experience on a 5-point scale. 
 
Study Population: 100 Consecutive scheduled screening colonoscopy patients 
meeting eligibility criteria.   
 
 
Eligibility Criteria 
 
Inclusion criteria  
1. 
Consecutive patients undergoing routine colonoscopy in an ambulatory non-
urgent setting will be eligible to participate in the study.   
2. 
Informed consent. 
3. 
Not participating in other clinical study. 
 

Exclusion criteria  
1. 
Previous GI surgery involving the colon or rectum. 
2. 
Known Pre-diagnosis of CRC. 
3. 
Previous history of IBD. 
4. 
High suspicion or diagnosis of genetic polyposis syndromes 
5. 
Known pathologic finding in previous CT scan or other imaging modalities 
 
Statistical Plan 
Sample Size  
Three (3) experienced (performed > 250 Colonoscopy per year) will perform a total of 
100 colonoscopies (100 patients). Each Colonoscopist will perform at least 25 
procedures (25/100). 
 
Statistical Analysis 
Since this is a single arm open label study without a control arm, only descriptive 
statistics will be used to define baseline demographic characteristics of patients and 
of the outcomes. Patients’ data and clinical parameters are given as means with 95% 
CI. 
 
 
Methodology  
All procedures will be performed during a single session:  
 
Screening 
• 
Eligible patients that agree to participate in the study will sign the related 
informed consent form in addition to the regular consent form for the colonoscopy.  
 
Procedure  
• 
Screening colonoscopy according to standard clinical practice using the 
standard equipment. The Colonoscopists is informed by AI system side-by-side real-
time display and audio notifications on findings suggestive of lesions. Highlighted 
findings by the System will be inspected by the Colonoscopists in real-time, the 
ultimate diagnosis of the lesion (polyp or false alarm) and decision on appropriate 
treatment (resection or not and resection technique) will remain in the responsibility 
of the colonoscopist alone. A nurse coordinator will record in real-time the results of 
these assessment on case report forms (number of detected polyps, additional 
polyps detected by the system that where missed by the colonoscopist, false alarm). 
• 
At the end of each procedure, the colonoscopist user experience will be 
evaluated using a scale of 1-5, the user will be asked “on a scale of 1-5 how useful 
did you find the system in this procedure”.  
 
Follow-up: 
• 
Patient safety follow up will be performed as regularly practiced at the 
digestive diseases institute, each adverse event will be registered in case report 
form.  
 
Study duration  
 

The overall enrollment period is expected to last approximately 3 months (assuming 
recruitment rate of 1 patient per day), but may extend for up to one year. 
 
Training  
• 
All experienced physician will have onboarding training 
• 
Observers will be trained on their role and questionnaire 
 
Statistical methods 
 
 
Cohorts: 
 For performance and safety: The ITT population will include all enrolled subjects. 
 
Regulatory compliance: 
This study will be subject for EC and Israeli Ministry of Health approval in accord with 
the Israeli MoH Clinical Trial Requirements (NOHAL 14, 2016). This Investigator 
Initiated study will comply with GCP (ISO14155) where the Investigators assumed 
the GCP responsibilities of the sponsor and investigator. 
The study will be submitted to the ethical review board of Shaare Zedek Medical 
Center. The study will be conducted in accordance with the Good Clinical Practice 
guidelines of the International Conference on Harmonization and the provisions of 
the Declaration of Helsinki.