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N/A N=100 Screening

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

Colonic Polyp

Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Number of Additional Polyps Detected by the DEEP System in Real Time Colonoscopy — 0.89 Added polyps detected per colonoscopy

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
AI polyp detection system based on deep learning (Device)
Age
Adult, Older Adult · 40+ yrs
Sex
All
Sponsor
Shaare Zedek Medical Center
Primary completion
Nov 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Additional Polyps Detected by the DEEP System in Real Time Colonoscopy
0.89
PRIMARY
The Rate of Adverse Events During the Study Attributed or Not to the Use of the DEEP System
SECONDARY
Rate of False Positives (False Alarms) Per Colonoscopy
3.87
SECONDARY
Colonoscopist User Experience While Using the DEEP System in a 5 Point Scale
3.9

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04693078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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