Effectiveness of Artificial Intelligence - Assisted Colonoscopy in Colorectal Neoplasms

Not Applicable

Not yet recruiting

• Conditions: Diagnosis; Colonic Polyp; Colonic Neoplasms
• Interventions: Device: The system based on real - time artificial intelligence - assisted for colonoscopy

• Registration Number: NCT06469671
• Lead Sponsor: State Scientific Centre of Coloproctology, Russian Federation

Brief Summary

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

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;

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-05
• Study First Submitted QC: 2024-06-17
• Last Update Submitted: 2024-06-17
• Study First Posted: 2024-06-21
• Last Update Posted: 2024-06-21
• Study Start: 2024-07
• Primary Completion: 2024-10
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Screening coloscopy is needed

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional colonoscopy	The system based on real - time artificial intelligence - assisted for colonoscopy	Conventional colonoscopy will be performed in this group
Artificial intelligence - assisted colonoscopy	The system based on real - time artificial intelligence - assisted for 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.

Primary Outcome Measures

Name	Time	Method
Adenoma detection rate	during the procedure	In each group, the percentage of patients with at least one histologically proven adenoma or carcinoma

Secondary Outcome Measures

Name	Time	Method
Number of polyps	during the procedure	In each group, the number of detected all type of polyps
Polyps detection rate	during the procedure	In each group, the number of patients with all type of neoplasms (polyps) was detected as a percentage of the total number of patients.
Number of adenomas	during the procedure	In each group, the number of detected adenomas

Trial Locations

Locations (1)

Airat Mingazov; 🇷🇺 Moscow, Russian Federation