AI Colorectal Polyp Detection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-24

Study Completion Date

2022-11-21

Brief Summary

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This study is intended to demonstrate the superiority of colorectal polyp detection using computer-assisted colonoscopy compared to conventional colonoscopy.

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Detailed Description

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Conditions

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Polyp Colorectal Adenoma Colon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Patients will be randomized 1:1, inspection with computer assisted colonoscopy: inspection with conventional colonoscopy.

Study Groups

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CAC Group

Inspection with computer assisted colonoscopy.

Group Type EXPERIMENTAL

EW10-EC02 (Endoscopy Support Program)

Intervention Type DEVICE

EW10-EC02 is intended to automatically detect the location of suspected polyps in colonoscopy exams. Identified polyps are highlighted to the clinician in real-time during the exam, as a video image superimposed on the endoscope monitor. EW10-EC02 is limited to the detection of suspected findings, and should not be used in lieu of full patient evaluation or relied upon to make or confirm a diagnosis.

CC Group

Inspection with conventional colonoscopy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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EW10-EC02 (Endoscopy Support Program)

EW10-EC02 is intended to automatically detect the location of suspected polyps in colonoscopy exams. Identified polyps are highlighted to the clinician in real-time during the exam, as a video image superimposed on the endoscope monitor. EW10-EC02 is limited to the detection of suspected findings, and should not be used in lieu of full patient evaluation or relied upon to make or confirm a diagnosis.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Average risk subjects undergoing their first colonoscopy (screening) or follow-up colonoscopy for previous history of polyps (surveillance interval of 3 years or greater)
* Patients aged 45 or older
* Patients who can provide an informed consent

Exclusion Criteria

* Patients with history of colon resection, Inflammatory Bowel Disease (IBD), Familial Adenomatous Polyposis (FAP), severe comorbidity, including end-stage cardiovascular/pulmonary/liver/renal disease
* Patients who are pregnant or are planning pregnancy during study period
* Patients who are not able to or refuse to give informed consent

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes