Efficacy of Artificial Intelligence-assisted Colonic Polyp Detection System

NCT ID: NCT05941689

Last Updated: 2023-10-10

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

1906 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-25

Study Completion Date

2023-09-30

Brief Summary

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This is a randomized controlled multicenter clinical trial of computer-aided detection (CADe) system for the adjuvant diagnosis of intestinal polyps/adenomas ever conducted in a Chinese population. In addition, this study will evaluate the effect of CADe system on adenoma detection of endoscopists under fatigue.

Detailed Description

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Conditions

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Adenoma Colon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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AI-assisted group

Subjects in this group undergo AI-assisted colonoscopy. The AI-assisted system not only has the function of automatic polyp detection, but also has the function of colonoscopy quality control.

Group Type EXPERIMENTAL

AI-assisted colonoscopy

Intervention Type DEVICE

AI can not only detect suspicious lesions timely, and label them in the field of view of the colonoscopy, but also monitor withdrawal speed and calculate the clean withdrawal time automatically.

control group

Subjects in this group undergo routine colonoscopy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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AI-assisted colonoscopy

AI can not only detect suspicious lesions timely, and label them in the field of view of the colonoscopy, but also monitor withdrawal speed and calculate the clean withdrawal time automatically.

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiaowei Liu, doctor

Role: PRINCIPAL_INVESTIGATOR

Xiangya Hospital of Central South University

Locations

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Xiangya Hospital Central South University

Changsha, Hunan, China

Site Status

Loudi Central Hospital

Loudi, Hunan, China

Site Status

Countries

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China

Other Identifiers

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202306499

Identifier Type: -

Identifier Source: org_study_id

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