Real-Time Artificial Intelligence Assissted Colonoscopy to Identify and Classify Polyps

NCT ID: NCT05718193

Last Updated: 2023-04-11

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

2868 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-03-15

Brief Summary

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To investigate the degree of the real-time detection and classification system for increasing the adenoma detection rate during colonoscopy.

Detailed Description

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Conditions

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Artificial Intelligence Colonoscopy Quality Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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The DeFrame Group

Subjects in the DeFrame group were treated with a real-time computer-aided polyp detection system named DeFrame during colonoscopy.

Group Type EXPERIMENTAL

DeFrame

Intervention Type DIAGNOSTIC_TEST

The DeFrame system is applicated during colonoscopy. The DeFrame system superimposes a rectangular box on the polyp lesion area in the colonoscopy field of view, notifying the endoscopists of the presence of the lesion.

The Classified DeFrame Group

Subjects in the Classified DeFrame group were treated with a real-time computer-aided polyp detection and classification system named Classified DeFrame during colonoscopy.

Group Type EXPERIMENTAL

Classified DeFrame

Intervention Type DIAGNOSTIC_TEST

The Classified DeFrame system is applicated during colonoscopy. The Classified DeFrame system superimposes a rectangular box on the polyp lesion area in the colonoscopy field of view, the color of the rectangle box will turn blue when the polyp is considered as an adenoma, notifying the endoscopists of the presence of the lesion.

The Control Group

Subjects in the control group underwent standard colonoscopy.

Group Type EXPERIMENTAL

conventional colonoscopy

Intervention Type DIAGNOSTIC_TEST

conventional colonoscopy

Interventions

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DeFrame

The DeFrame system is applicated during colonoscopy. The DeFrame system superimposes a rectangular box on the polyp lesion area in the colonoscopy field of view, notifying the endoscopists of the presence of the lesion.

Intervention Type DIAGNOSTIC_TEST

Classified DeFrame

The Classified DeFrame system is applicated during colonoscopy. The Classified DeFrame system superimposes a rectangular box on the polyp lesion area in the colonoscopy field of view, the color of the rectangle box will turn blue when the polyp is considered as an adenoma, notifying the endoscopists of the presence of the lesion.

Intervention Type DIAGNOSTIC_TEST

conventional colonoscopy

conventional colonoscopy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Aged 18 to 85 years old. Colonoscopies for primary CRC screening of the subjects are required.

Exclusion Criteria

History of CRC,inflammatory bowel disease, previous colonic resection, antithrombotic therapy precluding polyp resection.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Loudi Central Hospital

OTHER

Sponsor Role collaborator

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: STUDY_DIRECTOR

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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202112254

Identifier Type: -

Identifier Source: org_study_id

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