Effectiveness of Artificial Intelligence - Assisted Colonoscopy in Colorectal Neoplasms (ArtInCol)

State Scientific Centre of Coloproctology, Russian Federation

Status: Not yet enrolling

Conditions: Colonic Polyp; Colonic Neoplasms; Diagnosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06469671

7-24

Details and patient eligibility

About

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.

Full description

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;

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Screening coloscopy is needed

Exclusion criteria

• Indications for colonoscopy
• Previously detected colorectal neoplasms
• Previously performed colorectal surgery
• Colorectal cancer
• Inflammatory bowel disease

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

Artificial intelligence - assisted colonoscopy

Experimental group

Description:

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.

Treatment:

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

Conventional colonoscopy

Active Comparator group

Description:

Conventional colonoscopy will be performed in this group

Treatment:

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