Effectiveness of Artificial Intelligence - Assisted Colonoscopy in Colorectal Neoplasms

NCT ID: NCT06469671

Last Updated: 2024-06-21

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2024-12-31

Brief Summary

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The primary goal of this study is to estimate the effectiveness of a medical decision support system based on artificial intelligence in the endoscopic diagnosis of benign tumors.

Researchers will compare Adenoma detection rate between "artificial intelligence - assisted colonoscopy" and "conventional colonoscopy" groups to evaluate the clinical effectiveness of artificial intelligence model.

Detailed Description

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The primary outcome is adenoma detection rate per patient.

The secondary outcomes will be measured:

* Polyps detection rate (all type of lesions) per patient;
* Number of adenomas per patient;
* Number of polyps per patient;

Conditions

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Colonic Neoplasms Colonic Polyp Diagnosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Artificial intelligence - assisted colonoscopy

The decision making system based on artificial intelligence. Real - time artificial intelligence - assisted colonoscopy will be performed in this group.

Detection of polyps is based on real time fixing a frame on the screen.

Group Type EXPERIMENTAL

The system based on real - time artificial intelligence - assisted for colonoscopy

Intervention Type DEVICE

Russian medical decision support system based on artificial intelligence "ArtInCol"

Conventional colonoscopy

Conventional colonoscopy will be performed in this group

Group Type ACTIVE_COMPARATOR

The system based on real - time artificial intelligence - assisted for colonoscopy

Intervention Type DEVICE

Russian medical decision support system based on artificial intelligence "ArtInCol"

Interventions

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The system based on real - time artificial intelligence - assisted for colonoscopy

Russian medical decision support system based on artificial intelligence "ArtInCol"

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Screening coloscopy is needed

Exclusion Criteria

* Indications for colonoscopy
* Previously detected colorectal neoplasms
* Previously performed colorectal surgery
* Colorectal cancer
* Inflammatory bowel disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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State Scientific Centre of Coloproctology, Russian Federation

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sergey Achkasov

Role: PRINCIPAL_INVESTIGATOR

State scientific centre of coloproctology, Moscow

Locations

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Airat Mingazov

Moscow, , Russia

Site Status

Countries

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Russia

Central Contacts

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Dmitriy Shakhmatov

Role: CONTACT

+79035651441

Airat Mingazov

Role: CONTACT

89276951752

Facility Contacts

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Airat Mingazov

Role: primary

89276951752

Role: backup

Other Identifiers

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7-24

Identifier Type: -

Identifier Source: org_study_id

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