Detection of Colonic Polyps Via a Large Scale Artificial Intelligence (AI) System

Colonic Polyp Clinical Trial

Official title:

Detection of Colonic Polyps Via a Large Scale AI System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04693078
• Other study ID #: 0309-19-SZMC
• Status: Completed
• Phase: N/A
• Start date: May 18, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: February 2021
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Colonoscopy is the gold standard for detection and removal of precancerous lesions, and has been amply shown to reduce mortality. However, the miss rate for polyps during colonoscopies is 22-28%, while 20-24% of the missed lesions are histologically confirmed precancerous adenomas. To address this shortcoming, the investigators propose a new polyp detection system based on deep learning, which can alert the operator in real-time to the presence and location of polyps during a colonoscopy. The investigators dub the system DEEP: (DEEP) DEtection of Elusive Polyps. The DEEP system was trained on 3,611 hours of colonoscopy videos derived from two sources, and was validated on a set comprising 1,393 hours of video, coming from a third, unrelated source. For the validation set, the ground truth labelling was provided by offline gastroenterologist annotators, who were able to watch the video in slow-motion and pause/rewind as required; two or three specialist annotators examined each video.

This is a prospective, non-blinded, non-randomized pilot study of patients undergoing elective screening and surveillance colonoscopies using DEEP.

The aim of the study is to:

Assess the:

1. Number of additional polyps detected by the DEEP system in real time colonoscopy.

2. Safety by prospective assessment of the rate of adverse events during the study period attributed or not to the use of the DEEP system.

3. Stability of the DEEP system by measuring the rate of false positives (False Alarms) per colonoscopies 4 And to examine its feasibility and usefulness of in clinical practice by assessing the colonoscopist user experience while using the DEEP system in a 5 point scale.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Healthy subjects undergoing routine screening or surveillance colonoscopy in an ambulatory non urgent setting.

• Able to understand the study protocol and sign inform consent.

Exclusion Criteria:

• Previous surgery involving the colon or rectum

• Known diagnosis of colorectal cancer

• Known history of inflammatory bowel disease

• Known or suspected diagnosis of familial polyposis syndrome

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps
• Polyps

Intervention

Device:
• AI polyp detection system based on deep learning
A Polyp detection system based on deep learning and artificial intelligence, which can alert the operator in real-time to the presence and location of polyps during a colonoscopy.

Locations

Country	Name	City	State
Israel	Digestive Diseases Institute, Shaare Zedek Medical Center	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center	Google LLC.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Additional Polyps Detected by the DEEP System in Real Time Colonoscopy	During the colonoscopy procedure, in real time when a polyp is found, the colonoscopist will rate the polyp as an elusive polyp detected by the system that might have been missed or a polyp that would have been detected with or without the system.; The outcome measure will be reported as the average of additional polyps detected per colonoscopy by the DEEP system	Through study completion, an average of 12 months
Primary	The Rate of Adverse Events During the Study Attributed or Not to the Use of the DEEP System	Prospective assessment adverse events during the study. The following adverse event will be monitored: Perforation, bleeding, and cardiorespiratory adverse events during the procedure	Until discharge, assessed up to 7 days
Secondary	Rate of False Positives (False Alarms) Per Colonoscopy	During the colonoscopy procedure, in real time after each polyp found by the DEEP system, the colonoscopist will rate the polyp as either a true polyp or a false positive detection or a "false alarm" this measure will be reported as the average of false positive detection per colonoscopy	Through study completion, an average of 12 months
Secondary	Colonoscopist User Experience While Using the DEEP System in a 5 Point Scale	At the end of the procedures the colonoscopist will be requires to answer the question "from a scale of 1-5 how useful did you find the system in this procedure?", where higher scores represent more usefulness. This measure will be reported as the average score form all 100 procedures.	Through study completion, an average of 12 months